Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-28 @ 9:22 AM
Study NCT ID:
NCT04292535
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2020-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pontifex@msu.edu', 'phone': '517-432-5105', 'title': 'Matthew B. Pontifex', 'organization': 'Michigan State University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'As the present investigation was a Phase II Clinical Trial, the research design was not sufficiently powered for hypothesis testing. Given the potential risk of combining exercise with intranasal insulin the present investigation utilized a sample of healthy, non-diabetic, fasted college-aged adults to limit the potential for a serious adverse event.'}}, 'adverseEventsModule': {'timeFrame': 'Only during the two 90 minute sessions.', 'description': 'The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemic event', 'notes': 'Blood sugar fell below 70 mg/Dl or exhibited Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '9', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '9', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 20 minute exercise/control period and the cognitive assessments.', 'description': 'The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Manifestation of Any Symptom Following the Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '9', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)', 'description': 'The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size for Change in Behavioral Index of Inhibitory Control - RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 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A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.22'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '-0.17', 'upperLimit': '0.49'}, {'value': '-0.04', 'groupId': 'OG002', 'lowerLimit': '-0.28', 'upperLimit': '0.21'}, {'value': '-0.19', 'groupId': 'OG003', 'lowerLimit': '-0.40', 'upperLimit': '0.02'}, {'value': '-0.06', 'groupId': 'OG004', 'lowerLimit': '-0.37', 'upperLimit': '0.26'}, {'value': '-0.14', 'groupId': 'OG005', 'lowerLimit': '-0.46', 'upperLimit': '0.19'}, {'value': '-0.05', 'groupId': 'OG006', 'lowerLimit': '-0.14', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG007', 'lowerLimit': '-0.23', 'upperLimit': '0.33'}, {'value': '-0.26', 'groupId': 'OG008', 'lowerLimit': '-0.74', 'upperLimit': '0.23'}, {'value': '-0.12', 'groupId': 'OG009', 'lowerLimit': '-0.51', 'upperLimit': '0.28'}, {'value': '0.06', 'groupId': 'OG010', 'lowerLimit': '-0.18', 'upperLimit': '0.29'}, {'value': '-0.01', 'groupId': 'OG011', 'lowerLimit': '-0.25', 'upperLimit': '0.23'}, {'value': '0.01', 'groupId': 'OG012', 'lowerLimit': '-0.26', 'upperLimit': '0.27'}, {'value': '-0.13', 'groupId': 'OG013', 'lowerLimit': '-0.46', 'upperLimit': '0.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.17'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '0.08'}, {'value': '-0.01', 'groupId': 'OG002', 'lowerLimit': '-0.12', 'upperLimit': '0.10'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-0.09', 'upperLimit': '0.08'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-0.15', 'upperLimit': '0.15'}, {'value': '-0.06', 'groupId': 'OG005', 'lowerLimit': '-0.20', 'upperLimit': '0.07'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-0.12', 'upperLimit': '0.12'}, {'value': '0.00', 'groupId': 'OG007', 'lowerLimit': '-0.09', 'upperLimit': '0.09'}, {'value': '0.00', 'groupId': 'OG008', 'lowerLimit': '-0.08', 'upperLimit': '0.08'}, {'value': '-0.04', 'groupId': 'OG009', 'lowerLimit': '-0.16', 'upperLimit': '0.09'}, {'value': '0.01', 'groupId': 'OG010', 'lowerLimit': '-0.17', 'upperLimit': '0.19'}, {'value': '-0.03', 'groupId': 'OG011', 'lowerLimit': '-0.11', 'upperLimit': '0.04'}, {'value': '0.00', 'groupId': 'OG012', 'lowerLimit': '-0.09', 'upperLimit': '0.10'}, {'value': '0.15', 'groupId': 'OG013', 'lowerLimit': '0.09', 'upperLimit': '0.21'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '0.10'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '0.19'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '-0.14', 'upperLimit': '0.45'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '-0.28', 'upperLimit': '0.58'}, {'value': '-0.42', 'groupId': 'OG004', 'lowerLimit': '-1.00', 'upperLimit': '0.16'}, {'value': '0.06', 'groupId': 'OG005', 'lowerLimit': '-0.14', 'upperLimit': '0.26'}, {'value': '-0.05', 'groupId': 'OG006', 'lowerLimit': '-0.53', 'upperLimit': '0.42'}, {'value': '-0.21', 'groupId': 'OG007', 'lowerLimit': '-0.40', 'upperLimit': '-0.03'}, {'value': '-0.03', 'groupId': 'OG008', 'lowerLimit': '-0.37', 'upperLimit': '0.31'}, {'value': '-0.25', 'groupId': 'OG009', 'lowerLimit': '-0.52', 'upperLimit': '0.02'}, {'value': '-0.41', 'groupId': 'OG010', 'lowerLimit': '-0.98', 'upperLimit': '0.16'}, {'value': '0.12', 'groupId': 'OG011', 'lowerLimit': '-0.40', 'upperLimit': '0.64'}, {'value': '0.19', 'groupId': 'OG012', 'lowerLimit': '-0.54', 'upperLimit': '0.93'}, {'value': '0.20', 'groupId': 'OG013', 'lowerLimit': '-0.35', 'upperLimit': '0.75'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size of Change in Behavioral Index of Sustained Attention - RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.37', 'upperLimit': '0.00'}, {'value': '-0.16', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '-0.07'}, {'value': '-0.15', 'groupId': 'OG002', 'lowerLimit': '-0.49', 'upperLimit': '0.19'}, {'value': '-0.24', 'groupId': 'OG003', 'lowerLimit': '-0.54', 'upperLimit': '0.06'}, {'value': '-0.20', 'groupId': 'OG004', 'lowerLimit': '-0.36', 'upperLimit': '-0.03'}, {'value': '-0.22', 'groupId': 'OG005', 'lowerLimit': '-0.37', 'upperLimit': '-0.07'}, {'value': '-0.11', 'groupId': 'OG006', 'lowerLimit': '-0.37', 'upperLimit': '0.15'}, {'value': '-0.16', 'groupId': 'OG007', 'lowerLimit': '-0.29', 'upperLimit': '-0.03'}, {'value': '-0.05', 'groupId': 'OG008', 'lowerLimit': '-0.16', 'upperLimit': '0.07'}, {'value': '-0.16', 'groupId': 'OG009', 'lowerLimit': '-0.54', 'upperLimit': '0.23'}, {'value': '-0.18', 'groupId': 'OG010', 'lowerLimit': '-0.36', 'upperLimit': '0.01'}, {'value': '-0.09', 'groupId': 'OG011', 'lowerLimit': '-0.26', 'upperLimit': '0.09'}, {'value': '-0.19', 'groupId': 'OG012', 'lowerLimit': '-0.39', 'upperLimit': '0.00'}, {'value': '-0.16', 'groupId': 'OG013', 'lowerLimit': '-0.37', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '1.20'}, {'value': '0.81', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '1.73'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '-0.51', 'upperLimit': '0.62'}, {'value': '0.87', 'groupId': 'OG003', 'lowerLimit': '0.40', 'upperLimit': '1.35'}, {'value': '0.62', 'groupId': 'OG004', 'lowerLimit': '0.03', 'upperLimit': '1.20'}, {'value': '0.71', 'groupId': 'OG005', 'lowerLimit': '0.10', 'upperLimit': '1.32'}, {'value': '0.69', 'groupId': 'OG006', 'lowerLimit': '-0.13', 'upperLimit': '1.51'}, {'value': '0.54', 'groupId': 'OG007', 'lowerLimit': '0.06', 'upperLimit': '1.02'}, {'value': '0.36', 'groupId': 'OG008', 'lowerLimit': '-0.07', 'upperLimit': '0.80'}, {'value': '-0.21', 'groupId': 'OG009', 'lowerLimit': '-1.23', 'upperLimit': '0.80'}, {'value': '0.78', 'groupId': 'OG010', 'lowerLimit': '0.23', 'upperLimit': '1.32'}, {'value': '0.43', 'groupId': 'OG011', 'lowerLimit': '-0.12', 'upperLimit': '0.98'}, {'value': '0.90', 'groupId': 'OG012', 'lowerLimit': '0.33', 'upperLimit': '1.48'}, {'value': '0.60', 'groupId': 'OG013', 'lowerLimit': '-0.23', 'upperLimit': '1.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '0.23'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-0.21', 'upperLimit': '0.03'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '-0.20', 'upperLimit': '0.29'}, {'value': '0.23', 'groupId': 'OG003', 'lowerLimit': '0.02', 'upperLimit': '0.45'}, {'value': '0.02', 'groupId': 'OG004', 'lowerLimit': '-0.17', 'upperLimit': '0.21'}, {'value': '0.16', 'groupId': 'OG005', 'lowerLimit': '0.03', 'upperLimit': '0.28'}, {'value': '0.08', 'groupId': 'OG006', 'lowerLimit': '-0.15', 'upperLimit': '0.31'}, {'value': '0.03', 'groupId': 'OG007', 'lowerLimit': '-0.17', 'upperLimit': '0.24'}, {'value': '0.02', 'groupId': 'OG008', 'lowerLimit': '-0.18', 'upperLimit': '0.22'}, {'value': '0.02', 'groupId': 'OG009', 'lowerLimit': '-0.15', 'upperLimit': '0.20'}, {'value': '0.18', 'groupId': 'OG010', 'lowerLimit': '0.00', 'upperLimit': '0.36'}, {'value': '0.04', 'groupId': 'OG011', 'lowerLimit': '-0.25', 'upperLimit': '0.33'}, {'value': '-0.03', 'groupId': 'OG012', 'lowerLimit': '-0.19', 'upperLimit': '0.14'}, {'value': '-0.06', 'groupId': 'OG013', 'lowerLimit': '-0.35', 'upperLimit': '0.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'OG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '0.48'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '0.14'}, {'value': '-0.08', 'groupId': 'OG002', 'lowerLimit': '-0.77', 'upperLimit': '0.61'}, {'value': '-0.09', 'groupId': 'OG003', 'lowerLimit': '-0.29', 'upperLimit': '0.11'}, {'value': '0.26', 'groupId': 'OG004', 'lowerLimit': '-0.43', 'upperLimit': '0.96'}, {'value': '0.25', 'groupId': 'OG005', 'lowerLimit': '-0.36', 'upperLimit': '0.86'}, {'value': '-0.10', 'groupId': 'OG006', 'lowerLimit': '-0.48', 'upperLimit': '0.29'}, {'value': '-0.03', 'groupId': 'OG007', 'lowerLimit': '-0.33', 'upperLimit': '0.27'}, {'value': '0.34', 'groupId': 'OG008', 'lowerLimit': '-0.15', 'upperLimit': '0.83'}, {'value': '0.00', 'groupId': 'OG009', 'lowerLimit': '-0.22', 'upperLimit': '0.21'}, {'value': '0.04', 'groupId': 'OG010', 'lowerLimit': '-0.30', 'upperLimit': '0.37'}, {'value': '0.05', 'groupId': 'OG011', 'lowerLimit': '-0.30', 'upperLimit': '0.40'}, {'value': '0.10', 'groupId': 'OG012', 'lowerLimit': '-0.36', 'upperLimit': '0.57'}, {'value': '0.05', 'groupId': 'OG013', 'lowerLimit': '-0.37', 'upperLimit': '0.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.", 'unitOfMeasure': 'cohens d', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'FG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '9'}, {'groupId': 'FG013', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'comment': 'Condition stopped due to Blood Sugar Below 70 mg/dL (n = 1)', 'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'comment': 'Condition stopped due to Blood Sugar Below 70 mg/dL (n = 1)', 'groupId': 'FG012', 'numSubjects': '8'}, {'comment': 'Condition stopped due to Blood Sugar Below 70 mg/dL (n = 1) Condition stopped due to Report of Dizziness (n = 1)', 'groupId': 'FG013', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Condition stopped due to Blood Sugar Below 70 mg/dL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Report of Dizziness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}]}, {'type': 'Equipment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the mid-Michigan area.', 'preAssignmentDetails': '177 individuals were assessed for eligibility. 61 individuals were excluded (58 for failing medical screening, 1 diabetic, 1 unable to exercise, 1 history of epilepsy) 116 individuals were randomized using a serial stratification approach.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '9', 'groupId': 'BG013'}, {'value': '116', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'Passive Control - Placebo', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG001', 'title': 'Passive Control - 20 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG002', 'title': 'Passive Control - 40 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG003', 'title': 'Passive Control - 60 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG004', 'title': 'Passive Control - 80 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG005', 'title': 'Passive Control - 100 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG006', 'title': 'Passive Control - 120 IU', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG007', 'title': 'Acute Exercise - Placebo', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\nPlacebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG008', 'title': 'Acute Exercise - 20 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG009', 'title': 'Acute Exercise - 40 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG010', 'title': 'Acute Exercise - 60 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG011', 'title': 'Acute Exercise - 80 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG012', 'title': 'Acute Exercise - 100 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG013', 'title': 'Acute Exercise - 120 IU', 'description': '20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate.\n\n120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer'}, {'id': 'BG014', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '20.7', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '20.0', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '21.9', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '19.6', 'spread': '1.3', 'groupId': 'BG004'}, {'value': '20.8', 'spread': '2.5', 'groupId': 'BG005'}, {'value': '23.1', 'spread': '3.9', 'groupId': 'BG006'}, {'value': '19.8', 'spread': '1.5', 'groupId': 'BG007'}, {'value': '19.9', 'spread': '1.5', 'groupId': 'BG008'}, {'value': '21.8', 'spread': '3.9', 'groupId': 'BG009'}, {'value': '21.3', 'spread': '3.9', 'groupId': 'BG010'}, {'value': '20.2', 'spread': '1.8', 'groupId': 'BG011'}, {'value': '20.1', 'spread': '1.4', 'groupId': 'BG012'}, {'value': '20.1', 'spread': '2.4', 'groupId': 'BG013'}, {'value': '20.7', 'spread': '2.5', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}, {'value': '72', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '44', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '9', 'groupId': 'BG013'}, {'value': '109', 'groupId': 'BG014'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '9', 'groupId': 'BG014'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '96', 'groupId': 'BG014'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '9', 'groupId': 'BG013'}, {'value': '116', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '13.7', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '14.4', 'spread': '2.8', 'groupId': 'BG003'}, {'value': '13.6', 'spread': '2.7', 'groupId': 'BG004'}, {'value': '13.4', 'spread': '2.3', 'groupId': 'BG005'}, {'value': '15.6', 'spread': '2.6', 'groupId': 'BG006'}, {'value': '13.0', 'spread': '1.1', 'groupId': 'BG007'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'BG008'}, {'value': '15.1', 'spread': '3.4', 'groupId': 'BG009'}, {'value': '14.0', 'spread': '2.8', 'groupId': 'BG010'}, {'value': '13.7', 'spread': '2.1', 'groupId': 'BG011'}, {'value': '13.4', 'spread': '1.4', 'groupId': 'BG012'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'BG013'}, {'value': '13.9', 'spread': '2.2', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WASI-II (IQ)', 'classes': [{'categories': [{'measurements': [{'value': '104.7', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '105.0', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '98.3', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '110.0', 'spread': '6.4', 'groupId': 'BG003'}, {'value': '113.6', 'spread': '10.1', 'groupId': 'BG004'}, {'value': '120.6', 'spread': '12.7', 'groupId': 'BG005'}, {'value': '110.7', 'spread': '10.5', 'groupId': 'BG006'}, {'value': '104.4', 'spread': '4.3', 'groupId': 'BG007'}, {'value': '110.8', 'spread': '18.8', 'groupId': 'BG008'}, {'value': '107.7', 'spread': '8.0', 'groupId': 'BG009'}, {'value': '110.8', 'spread': '4.1', 'groupId': 'BG010'}, {'value': '103.5', 'spread': '8.7', 'groupId': 'BG011'}, {'value': '108.2', 'spread': '16.8', 'groupId': 'BG012'}, {'value': '101.2', 'spread': '17.8', 'groupId': 'BG013'}, {'value': '107.5', 'spread': '9.9', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'description': 'Wechsler Abbreviated Scale of Intelligence (2nd Edition) Scores represents performance on the Vocabulary and Matrix Reasoning subtests. For each test the scores are converted to T scores. T scores on each scale are summed together. Scores range from 45 to 160 with higher values representing better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting blood glucose (mg/dL)', 'classes': [{'categories': [{'measurements': [{'value': '94.1', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '96.0', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '99.0', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '91.9', 'spread': '3.5', 'groupId': 'BG003'}, {'value': '96.4', 'spread': '6.5', 'groupId': 'BG004'}, {'value': '94.4', 'spread': '9.4', 'groupId': 'BG005'}, {'value': '97.8', 'spread': '7.3', 'groupId': 'BG006'}, {'value': '92.2', 'spread': '9.4', 'groupId': 'BG007'}, {'value': '97.4', 'spread': '7.9', 'groupId': 'BG008'}, {'value': '87.1', 'spread': '9.6', 'groupId': 'BG009'}, {'value': '93.1', 'spread': '9.3', 'groupId': 'BG010'}, {'value': '96.3', 'spread': '7.3', 'groupId': 'BG011'}, {'value': '92.7', 'spread': '9.6', 'groupId': 'BG012'}, {'value': '96.0', 'spread': '9.5', 'groupId': 'BG013'}, {'value': '94.6', 'spread': '8.6', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aerobic fitness percentile', 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '28.8', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '54.5', 'spread': '24.0', 'groupId': 'BG003'}, {'value': '35.9', 'spread': '23.1', 'groupId': 'BG004'}, {'value': '53.6', 'spread': '36.3', 'groupId': 'BG005'}, {'value': '41.7', 'spread': '26.9', 'groupId': 'BG006'}, {'value': '59.2', 'spread': '26.9', 'groupId': 'BG007'}, {'value': '45.2', 'spread': '23.7', 'groupId': 'BG008'}, {'value': '48.7', 'spread': '34.5', 'groupId': 'BG009'}, {'value': '52.0', 'spread': '28.5', 'groupId': 'BG010'}, {'value': '55.8', 'spread': '23.2', 'groupId': 'BG011'}, {'value': '71.8', 'spread': '23.2', 'groupId': 'BG012'}, {'value': '28.8', 'spread': '10.0', 'groupId': 'BG013'}, {'value': '46.9', 'spread': '24.8', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'description': 'Relative peak oxygen consumption (ml/kg/min) was measured using indirect calorimetry during a maximal exercise test and then converted to percentiles based upon normative data taking into account age and biological sex. Percentiles range from 3 to 97 with higher values reflecting a greater aerobic capacity.', 'unitOfMeasure': 'percentile', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-19', 'size': 238581, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-19T14:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind, placebo controlled trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2020-02-28', 'resultsFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-27', 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol', 'timeFrame': 'During the 20 minute exercise/control period and the cognitive assessments.', 'description': 'The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.'}, {'measure': 'Number of Participants With Manifestation of Any Symptom Following the Protocol', 'timeFrame': 'Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)', 'description': 'The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.'}, {'measure': 'Effect Size for Change in Behavioral Index of Inhibitory Control - RT', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size of Change in Behavioral Index of Sustained Attention - RT', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}, {'measure': 'Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task', 'timeFrame': 'Prior to intranasal insulin administration relative to 30 minutes following', 'description': "The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.\n\nEffect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intranasal Insulin', 'Cognition', 'Exercise', 'Physical Activity'], 'conditions': ['Insulin', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '33856613', 'type': 'DERIVED', 'citation': 'Gwizdala KL, Ferguson DP, Kovan J, Novak V, Pontifex MB. Placebo controlled phase II clinical trial: Safety and efficacy of combining intranasal insulin & acute exercise. Metab Brain Dis. 2021 Aug;36(6):1289-1303. doi: 10.1007/s11011-021-00727-2. Epub 2021 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.', 'detailedDescription': 'Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must be over the age of 18..\n2. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.\n\nExclusion Criteria:\n\n1. Lack of consent.\n2. Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.\n3. Type I or Type II Diabetes\n4. Self-reported pregnancy\n5. Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).'}, 'identificationModule': {'nctId': 'NCT04292535', 'briefTitle': 'Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise', 'orgStudyIdInfo': {'id': 'STUDY00000804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Passive Control', 'description': '20 minute sedentary control period during which participants watched an emotionally neutral video.', 'interventionNames': ['Drug: Placebo into the intranasal mucosa', 'Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa']}, {'type': 'EXPERIMENTAL', 'label': 'Acute Exercise', 'description': '20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video.', 'interventionNames': ['Drug: Placebo into the intranasal mucosa', 'Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa', 'Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa']}], 'interventions': [{'name': 'Placebo into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': '6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}, {'name': '20 IU NovoLog Insulin aspart into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['NovoLog Insulin aspart'], 'description': '5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}, {'name': '40 IU NovoLog Insulin aspart into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['NovoLog Insulin aspart'], 'description': '4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}, {'name': '60 IU NovoLog Insulin aspart into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['NovoLog Insulin aspart'], 'description': '3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}, {'name': '80 IU NovoLog Insulin aspart into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['NovoLog Insulin aspart'], 'description': '2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}, {'name': '100 IU NovoLog Insulin aspart into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['NovoLog Insulin aspart'], 'description': '1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}, {'name': '120 IU NovoLog Insulin aspart into the intranasal mucosa', 'type': 'DRUG', 'otherNames': ['NovoLog Insulin aspart'], 'description': '6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer', 'armGroupLabels': ['Acute Exercise', 'Passive Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Department of Kinesiology', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}], 'overallOfficials': [{'name': 'Matthew B Pontifex, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available following primary publication of the results.', 'ipdSharing': 'YES', 'description': 'Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.', 'accessCriteria': 'By request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matthew B. Pontifex, Ph.D.', 'investigatorAffiliation': 'Michigan State University'}}}}