Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04664205
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbsmith@email.unc.edu', 'phone': '919-962-2574', 'title': 'Abbie Smith-Ryan, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signing the informed consent through the end of the study, a total of up to approximately 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'High Intensity Interval Training', 'description': 'High Intensity Interval Exercise: One session of high intensity interval exercise', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Moderate Intensity Continuous Training', 'description': 'Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Session', 'description': 'Control: No exercise, resting measures', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Energy Expenditure Between HIIT and MICT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Interval Training', 'description': 'High Intensity Interval Exercise: One session of high intensity interval exercise'}, {'id': 'OG001', 'title': 'Moderate Intensity Continuous Training', 'description': 'Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise'}, {'id': 'OG002', 'title': 'Control Session', 'description': 'Control: No exercise, resting measures'}], 'classes': [{'categories': [{'measurements': [{'value': '264.5', 'spread': '80.9', 'groupId': 'OG000'}, {'value': '225.5', 'spread': '57.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'During exercise', 'description': 'Energy expenditure measured via indirect calorimetry (kcals) during exercise.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no exercise during the control session; therefore, this outcome does not apply for control trial.'}, {'type': 'PRIMARY', 'title': 'Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Interval Training', 'description': 'High Intensity Interval Exercise: One session of high intensity interval exercise'}, {'id': 'OG001', 'title': 'Moderate Intensity Continuous Training', 'description': 'Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise'}, {'id': 'OG002', 'title': 'Control Session', 'description': 'Control: No exercise, resting measures'}], 'classes': [{'title': 'During exercise', 'categories': [{'measurements': [{'value': '8.46', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '7.11', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': '1 hour post', 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 hour post exercise', 'description': 'Lactate measured using capillary finger prick (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no exercise during the control session; therefore, this outcome does not apply for control trial.'}, {'type': 'SECONDARY', 'title': 'Change in Continuous Glucose After Exercise Into Overnight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Interval Training', 'description': 'High Intensity Interval Exercise: One session of high intensity interval exercise'}, {'id': 'OG001', 'title': 'Moderate Intensity Continuous Training', 'description': 'Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise'}, {'id': 'OG002', 'title': 'Control Session', 'description': 'Control: No exercise, resting measures'}], 'classes': [{'title': 'Immediately post exercise', 'categories': [{'measurements': [{'value': '155.2', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '146.9', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '124.5', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Overnight', 'categories': [{'measurements': [{'value': '139.7', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '165.6', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '150.3', 'spread': '7.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post-exercise and Overnight', 'description': "Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Intensity Interval Training, Moderate Intensity Continuous Training, Control', 'description': 'Participants randomly assigned to this arm will first receive high intensity interval training and then randomly assigned to both moderate intensity continuous training and control session, on different days.\n\nHigh Intensity Interval Exercise: One session of high intensity interval exercise\n\nModerate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise\n\nControl: No exercise, resting measures'}, {'id': 'FG001', 'title': 'Moderate Intensity Continuous Training, High Intensity Training, Control', 'description': 'Participants randomly assigned to this arm will first receive moderate intensity continuous training then randomly assigned to both high intensity interval training and a control session, on different days.\n\nHigh Intensity Interval Exercise: One session of high intensity interval exercise\n\nModerate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise\n\nControl: No exercise, resting measures'}, {'id': 'FG002', 'title': 'Control Session, High Intensity Interval Training, Moderate Intensity Continuous Training', 'description': 'Participants randomly assigned to this arm will first complete a control session (no exercise) and then randomly assigned to both by a high intensity interval training and moderate intensity continuous training session, on different days.\n\nHigh Intensity Interval Exercise: One session of high intensity interval exercise\n\nModerate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise\n\nControl: No exercise, resting measures'}], 'periods': [{'title': 'First Exercise Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Exercise Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Exercise Session', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a cross-over design with all participants completing all treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants were randomly assigned to receive control session, high intensity interval training, and moderate intensity continuous training on different days.\n\nHigh Intensity Interval Exercise: One session of high intensity interval exercise\n\nModerate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise\n\nControl: No exercise, resting measures'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Percent Body Fat', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body fat percentage determined from whole body dual energy x-ray absorptiometry', 'unitOfMeasure': 'percent body fat', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-17', 'size': 278828, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-08T14:14', 'hasProtocol': True}, {'date': '2021-09-17', 'size': 318156, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-08T14:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2020-12-04', 'resultsFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-08', 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Energy Expenditure Between HIIT and MICT', 'timeFrame': 'During exercise', 'description': 'Energy expenditure measured via indirect calorimetry (kcals) during exercise.'}, {'measure': 'Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism', 'timeFrame': 'Baseline, 1 hour post exercise', 'description': 'Lactate measured using capillary finger prick (mmol/L).'}], 'secondaryOutcomes': [{'measure': 'Change in Continuous Glucose After Exercise Into Overnight', 'timeFrame': 'Immediately post-exercise and Overnight', 'description': "Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge about exercise. Unlike traditional moderate intensity continuous training (MICT) which requires extended periods of time, high intensity interval training (HIIT) requires minimal time (\\~10 minutes of exercise per session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism. The extent to which these exercise strategies alter metabolomic signatures of carbohydrate, fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults with T1D. Using a randomized cross-over approach, the primary aim is to compare the metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An additional aim will be to characterize the influence of biological sex and physiological outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of these subjects. Outcomes from the present study, with existing data from our team, will lay the foundation for a larger diet and exercise lifestyle intervention that will ultimately lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin\n* Last hemoglobin A1c \\<9%\n* 18-51 years\n* Duration of T1D: ≥ 1 year\n* Body mass index (BMI) \\<30 kg/m\\^2\n* Generally healthy, with no conditions that could influence the outcome of the trial, and in the judgement of the investigators is a good candidate for the study, based on a review of health history\n\nExclusion Criteria:\n\n* Physician diagnosis of active diabetic retinopathy that could be worsened by exercise\n* Physician diagnosis of peripheral neuropathy with insensate feet\n* Physician diagnosis of autonomic neuropathy\n* Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin.\n* Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months\n* Diabetic ketoacidosis in the last 6 months\n* Has a closed-loop pump and not willing to use manual mode\n* Physician diagnosis of cardiovascular disease that would affect exercise tolerance\n* Currently doing HIIT\n* Severely impaired hearing or speech\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04664205', 'acronym': 'HI1T', 'briefTitle': 'Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes', 'orgStudyIdInfo': {'id': '20-3100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity interval training, Moderate Intensity Continuous Training, Control', 'description': 'Participants randomly assigned to this arm will first receive high intensity interval training and then randomly assigned to both moderate intensity continuous training and control session, on different days.', 'interventionNames': ['Other: High Intensity Interval Exercise', 'Other: Moderate Intensity Continuous Exercise', 'Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Intensity Continuous Training, High Intensity Training, Control', 'description': 'Participants randomly assigned to this arm will first receive moderate intensity continuous training then randomly assigned to both high intensity interval training and a control session, on different days.', 'interventionNames': ['Other: High Intensity Interval Exercise', 'Other: Moderate Intensity Continuous Exercise', 'Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Control session, High intensity interval training, moderate intensity continuous training', 'description': 'Participants randomly assigned to this arm will first complete a control session (no exercise) and then randomly assigned to both by a high intensity interval training and moderate intensity continuous training session, on different days.', 'interventionNames': ['Other: High Intensity Interval Exercise', 'Other: Moderate Intensity Continuous Exercise', 'Other: Control']}], 'interventions': [{'name': 'High Intensity Interval Exercise', 'type': 'OTHER', 'description': 'One session of high intensity interval exercise', 'armGroupLabels': ['Control session, High intensity interval training, moderate intensity continuous training', 'High intensity interval training, Moderate Intensity Continuous Training, Control', 'Moderate Intensity Continuous Training, High Intensity Training, Control']}, {'name': 'Moderate Intensity Continuous Exercise', 'type': 'OTHER', 'description': 'One session of calorically matched moderate intensity exercise', 'armGroupLabels': ['Control session, High intensity interval training, moderate intensity continuous training', 'High intensity interval training, Moderate Intensity Continuous Training, Control', 'Moderate Intensity Continuous Training, High Intensity Training, Control']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No exercise, resting measures', 'armGroupLabels': ['Control session, High intensity interval training, moderate intensity continuous training', 'High intensity interval training, Moderate Intensity Continuous Training, Control', 'Moderate Intensity Continuous Training, High Intensity Training, Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Applied Physiology Laboratory', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Abbie Smith-Ryan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 1 year and ending 2 years following article publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Diabetes Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}