Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-02 @ 11:36 AM
Study NCT ID:
NCT05153395
Status:
SUSPENDED
Last Update Posted:
2025-12-19
First Post:
2021-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069336', 'term': 'Neurovascular Coupling'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D002560', 'term': 'Cerebrovascular Circulation'}, {'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'whyStopped': 'Interim data and power analysis', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of cerebral blood flow', 'timeFrame': 'Change from baseline at minute 15', 'description': 'Measured with trans-cranial Doppler ultrasound (cm/s) or arterial spin labeling (mL/100 g/min)'}], 'secondaryOutcomes': [{'measure': 'Amount of muscle sympathetic nerve activity (MSNA)', 'timeFrame': 'Change from baseline at minute 15', 'description': 'MSNA burst incidence (bursts/100 heart beats)'}, {'measure': 'Amount of leg blood flow', 'timeFrame': 'Change from baseline at minute 15', 'description': 'Measured with Doppler ultrasound (mL/min)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Vasodilation', 'Insulin Resistance', 'Autonomic Dysfunction', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to examine the impact of increases in brain insulin on sympathetic nervous system activity, as well as peripheral and cerebral blood flow in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adult men and women;\n* 18-45 years of age;\n* BMI \\>18 kg/m2;\n* non-pregnant/non-breastfeeding;\n* non-nicotine users;\n\nExclusion Criteria:\n\n* taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic\n\nSelf-reported history of:\n\n* hepatic, renal, pulmonary, cardiovascular, or neurological disease;\n* stroke or neurovascular disease;\n* bleeding/clotting disorders;\n* sleep apnea or other sleep disorders;\n* diabetes;\n* smoking;\n* history of alcoholism or substance abuse;\n* hypertension;\n* respiratory disease;\n* active cancer;\n* autoimmune disease.'}, 'identificationModule': {'nctId': 'NCT05153395', 'briefTitle': 'Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Novel Treatment for Brain Insulin Resistance and Hypoperfusion', 'orgStudyIdInfo': {'id': '2057288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin (Doppler)', 'description': 'Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.', 'interventionNames': ['Other: Carbon dioxide breathing', 'Other: Neurovascular Coupling', 'Drug: Human insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin (MRI)', 'description': 'Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.', 'interventionNames': ['Other: Carbon dioxide breathing', 'Drug: Human insulin']}, {'type': 'OTHER', 'label': 'Time Control (Doppler)', 'description': 'Time control only', 'interventionNames': ['Other: Carbon dioxide breathing', 'Other: Neurovascular Coupling']}], 'interventions': [{'name': 'Carbon dioxide breathing', 'type': 'OTHER', 'description': 'Hypercapnic (5% carbon dioxide) air will be administered before and after intra-nasal insulin exposure.', 'armGroupLabels': ['Insulin (Doppler)', 'Insulin (MRI)', 'Time Control (Doppler)']}, {'name': 'Neurovascular Coupling', 'type': 'OTHER', 'description': 'Participants will be asked to repeatedly open and close their eyes. With eyes open, participants will focus on a visual image. This will be done before and after intra-nasal insulin exposure.', 'armGroupLabels': ['Insulin (Doppler)', 'Time Control (Doppler)']}, {'name': 'Human insulin', 'type': 'DRUG', 'description': 'Participants will be administered human insulin (160 IU) as a bolus using an intra-nasal device.', 'armGroupLabels': ['Insulin (Doppler)', 'Insulin (MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Jacqueline K Limberg, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jacqueline K Limberg, PhD', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}