Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT03203694
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Walking and Heating on Vascular Function in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'padillaja@missouri.edu', 'phone': '(573) 882-7056', 'title': 'Jaume Padilla', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks: (Walking: Intervention arm in diabetics; Walking: No intervention in diabetics) 7 days: (Lower body heating: Intervention arm in healthy subjects; Lower body heating: Intervention arm in diabetics) 1 day (1 session): (Walking: Healthy cohort as reference controls; Lower body heating: Healthy cohort as reference controls)', 'eventGroups': [{'id': 'EG000', 'title': 'Walking: Intervention Arm in Diabetics', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Walking: No Intervention in Diabetics', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Walking: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Lower Body Heating: Intervention Arm in Healthy Subjects', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Lower Body Heating: Intervention Arm in Diabetics', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Lower Body Heating: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic response to contrast agent', 'notes': 'Experience of allergic skin reaction to Definity (Perflutren) contrast agent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovegal Reaction', 'notes': 'Vaso-vegal reaction in response to IV placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking: Intervention Arm in Diabetics', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.'}, {'id': 'OG001', 'title': 'Walking: No Intervention in Diabetics', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.'}, {'id': 'OG002', 'title': 'Walking: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.'}, {'id': 'OG003', 'title': 'Lower Body Heating: Intervention Arm in Healthy Subjects', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).'}, {'id': 'OG004', 'title': 'Experimental: Lower Body Heating: Intervention Arm in Diabetics', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.'}, {'id': 'OG005', 'title': 'Lower Body Heating: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.'}], 'classes': [{'categories': [{'measurements': [{'value': '133.6', 'spread': '48.7', 'groupId': 'OG002'}, {'value': '8.92', 'spread': '2.26', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.', 'description': 'Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed at baseline (t0) and after 60 minutes of insulin stimulation (t60).', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes data from participants who were assigned to an intervention arm are reported under Outcome 2 (change from baseline to post-intervention).'}, {'type': 'PRIMARY', 'title': 'Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking: Intervention Arm in Diabetics', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.'}, {'id': 'OG001', 'title': 'Walking: No Intervention in Diabetics', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.'}, {'id': 'OG002', 'title': 'Walking: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.'}, {'id': 'OG003', 'title': 'Lower Body Heating: Intervention Arm in Healthy Subjects', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).'}, {'id': 'OG004', 'title': 'Lower Body Heating: Intervention Arm in Diabetics', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.'}, {'id': 'OG005', 'title': 'Lower Body Heating: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '47.3', 'groupId': 'OG000'}, {'value': '-17.6', 'spread': '21.4', 'groupId': 'OG001'}, {'value': '60.2', 'spread': '18.5', 'groupId': 'OG003'}, {'value': '11.1', 'spread': '3.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline insulin-stimulated leg blood flow following 1 heating session, 7 days of heating intervention, or 8 weeks of walking intervention/no intervention.', 'description': 'Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed pre-intervention and post-intervention at baseline (t0) and after 60 minutes of insulin stimulation (t60). Outcome measure indicates whether percent change in insulin-stimulated blood flow increased or decreased following intervention. Interventions that show an increase demonstrate an improvement in insulin-stimulated blood flow.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes data from participants who were not assigned a treatment arm are reported under Outcome 1 (Percent change in insulin-stimulated blood flow).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Walking: Intervention Arm in Diabetics', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.\n\nWalking: Intervention arm in diabetics: The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.'}, {'id': 'FG001', 'title': 'Walking: No Intervention in Diabetics', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.\n\nWalking: No intervention in diabetics: Subjects will be instructed to continue their usual lifestyle for 8 weeks.'}, {'id': 'FG002', 'title': 'Walking: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.\n\nWalking: Healthy cohort as reference controls: Subjects will be studied at one time only.'}, {'id': 'FG003', 'title': 'Lower Body Heating: Intervention Arm in Healthy Subjects', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).\n\nLower body heating: Intervention arm in healthy subjects: This intervention consists of 60 minutes of lower body heating (40-42 degree C).'}, {'id': 'FG004', 'title': 'Lower Body Heating: Intervention Arm in Diabetics', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.\n\nLower body heating: Intervention arm in diabetics: This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.'}, {'id': 'FG005', 'title': 'Lower Body Heating: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.\n\nLower body heating: Healthy cohort as reference controls: Subjects will be studied at one time only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Walking: Intervention Arm in Diabetics', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.\n\nWalking: Intervention arm in diabetics: The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.'}, {'id': 'BG001', 'title': 'Walking: No Intervention in Diabetics', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.\n\nWalking: No intervention in diabetics: Subjects will be instructed to continue their usual lifestyle for 8 weeks.'}, {'id': 'BG002', 'title': 'Walking: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.\n\nWalking: Healthy cohort as reference controls: Subjects will be studied at one time only.'}, {'id': 'BG003', 'title': 'Lower Body Heating: Intervention Arm in Healthy Subjects', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).\n\nLower body heating: Intervention arm in healthy subjects: This intervention consists of 60 minutes of lower body heating (40-42 degree C).'}, {'id': 'BG004', 'title': 'Lower Body Heating: Intervention Arm in Diabetics', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.\n\nLower body heating: Intervention arm in diabetics: This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.'}, {'id': 'BG005', 'title': 'Lower Body Heating: Healthy Cohort as Reference Controls', 'description': 'Subjects will be studied at one time only.\n\nLower body heating: Healthy cohort as reference controls: Subjects will be studied at one time only.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'categories': [{'title': '<=18 years', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}, {'title': '>=65 years', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', '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'}]}, {'title': 'Asian', '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'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}]}, {'title': 'More than one race', '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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '97', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '36.9', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '23.5', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '25.1', 'spread': '4.2', 'groupId': 'BG003'}, {'value': '35.9', 'spread': '1.2', 'groupId': 'BG004'}, {'value': '23.7', 'spread': '2.2', 'groupId': 'BG005'}, {'value': '29.6', 'spread': '2.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Drop out subjects are not included in the BMI calculation.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-08', 'size': 300171, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-27T11:13', 'hasProtocol': True}, {'date': '2020-07-08', 'size': 123392, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-01T16:46', 'hasProtocol': False}, {'date': '2021-03-10', 'size': 273877, 'label': 'Informed Consent Form: Lower body heating', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-27T11:14', 'hasProtocol': False}, {'date': '2018-04-11', 'size': 141729, 'label': 'Informed Consent Form: Lower body heating: Healthy cohort as reference controls', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-27T12:02', 'hasProtocol': False}, {'date': '2019-04-10', 'size': 333218, 'label': 'Informed Consent Form: Walking', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-27T12:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to either a walking, a lower body heating, or no intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2017-06-23', 'resultsFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-01', 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin-stimulated Leg Blood Flow Calculated as Percent Change (t0, t60)', 'timeFrame': 'Percent change from baseline leg blood flow during 60 minutes of insulin stimulation.', 'description': 'Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed at baseline (t0) and after 60 minutes of insulin stimulation (t60).'}, {'measure': 'Net Change in Insulin-stimulated Leg Blood Flow Calculated as Percent Change From Pre-intervention (t0,t60) to Post-intervention (t0,t60).', 'timeFrame': 'Change from baseline insulin-stimulated leg blood flow following 1 heating session, 7 days of heating intervention, or 8 weeks of walking intervention/no intervention.', 'description': 'Measure of blood flow in response to insulin. Blood flow is measured via Doppler ultrasound at the femoral artery. Measurements are performed pre-intervention and post-intervention at baseline (t0) and after 60 minutes of insulin stimulation (t60). Outcome measure indicates whether percent change in insulin-stimulated blood flow increased or decreased following intervention. Interventions that show an increase demonstrate an improvement in insulin-stimulated blood flow.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to determine the effects of increased walking and lower body heating on leg vascular function in patients with type 2 diabetes (T2D).', 'detailedDescription': 'The notion that habitual aerobic exercise increases insulin-induced vasodilation is largely founded on rodent studies, hence the urgent need for human studies, especially in patients with type 2 diabetes (T2D). For example, it remains unknown if increased walking, the most common form of physical activity, enhances skeletal muscle vasodilator actions of insulin in T2D. In addition, the molecular mechanisms by which exercise improves vasoreactivity to insulin have not been examined in humans. The investigators propose that in T2D patients who are sedentary (i.e., the vast majority), increased leg blood flow with walking or local heating signifies a vital strategy to correct vascular insulin resistance. This study will establish whether increased physical activity and associated hemodynamic forces (e.g., shear stress) are a direct form of vascular medicine in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with type 2 diabetes who are overweight and obese (BMI 25-50 kg/m2), 35 to 65 years of age, and sedentary (\\<60 minutes structured exercise/week). Healthy volunteers without type 2 diabetes: 18 to 65 years of age.\n\nExclusion Criteria:\n\n1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke;\n2. renal or hepatic diseases;\n3. active cancer;\n4. autoimmune diseases;\n5. immunosuppressant therapy;\n6. excessive alcohol consumption (\\>14 drinks/week for men; \\>7 drinks/week for women);\n7. current tobacco use;\n8. pregnancy;\n9. mobility limitations;\n10. foot ulcers;\n11. diabetic neuropathy\n12. uncontrolled hypertension (\\>=180 systolic / 100 diastolic mmHg)'}, 'identificationModule': {'nctId': 'NCT03203694', 'briefTitle': 'Effects of Walking and Heating on Vascular Function in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Restoring Vasodilator Actions of Insulin in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2008181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walking: Intervention arm in diabetics', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.', 'interventionNames': ['Behavioral: Walking: Intervention arm in diabetics']}, {'type': 'EXPERIMENTAL', 'label': 'Walking: No intervention in diabetics', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.', 'interventionNames': ['Other: Walking: No intervention in diabetics']}, {'type': 'OTHER', 'label': 'Walking: Healthy cohort as reference controls', 'description': 'Subjects will be studied at one time only.', 'interventionNames': ['Other: Walking: Healthy cohort as reference controls']}, {'type': 'EXPERIMENTAL', 'label': 'Lower body heating: Intervention arm in healthy subjects', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).', 'interventionNames': ['Behavioral: Lower body heating: Intervention arm in healthy subjects']}, {'type': 'EXPERIMENTAL', 'label': 'Lower body heating: Intervention arm in diabetics', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.', 'interventionNames': ['Behavioral: Lower body heating: Intervention arm in diabetics']}, {'type': 'OTHER', 'label': 'Lower body heating: Healthy cohort as reference controls', 'description': 'Subjects will be studied at one time only.', 'interventionNames': ['Other: Lower body heating: Healthy cohort as reference controls']}], 'interventions': [{'name': 'Walking: Intervention arm in diabetics', 'type': 'BEHAVIORAL', 'description': 'The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.', 'armGroupLabels': ['Walking: Intervention arm in diabetics']}, {'name': 'Walking: No intervention in diabetics', 'type': 'OTHER', 'description': 'Subjects will be instructed to continue their usual lifestyle for 8 weeks.', 'armGroupLabels': ['Walking: No intervention in diabetics']}, {'name': 'Walking: Healthy cohort as reference controls', 'type': 'OTHER', 'description': 'Subjects will be studied at one time only.', 'armGroupLabels': ['Walking: Healthy cohort as reference controls']}, {'name': 'Lower body heating: Intervention arm in healthy subjects', 'type': 'BEHAVIORAL', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C).', 'armGroupLabels': ['Lower body heating: Intervention arm in healthy subjects']}, {'name': 'Lower body heating: Intervention arm in diabetics', 'type': 'BEHAVIORAL', 'description': 'This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.', 'armGroupLabels': ['Lower body heating: Intervention arm in diabetics']}, {'name': 'Lower body heating: Healthy cohort as reference controls', 'type': 'OTHER', 'description': 'Subjects will be studied at one time only.', 'armGroupLabels': ['Lower body heating: Healthy cohort as reference controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Jaume Padilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jaume Padilla', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}