Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-01 @ 10:42 PM
Study NCT ID:
NCT01883258
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2013-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2013-06-13', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vascular endothelial function', 'timeFrame': 'At baseline and after 8 weeks of exercise training', 'description': 'Brachial flow mediated dilation using ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Change in factors related with endothelial function', 'timeFrame': 'At baseline and after 8 weeks of exercise training', 'description': 'Blood and cellular markers of adiponectin, oxidative stress and inflammation.'}, {'measure': 'Change in arterial stiffness', 'timeFrame': 'At baseline and after 8 weeks of exercise training', 'description': 'Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.'}, {'measure': 'Change in cardiac function', 'timeFrame': 'At baseline and after 8 weeks of exercise training', 'description': 'Left ventricular systolic and diastolic function will be measured using echocardiography.'}, {'measure': 'Change in maximal oxygen consumption', 'timeFrame': 'At baseline and after 8 weeks of exercise training', 'description': 'Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The study objectives are:\n\n1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.\n2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.\n3. To examine the mechanisms underlying the exercise-related changes in cardiovascular function.\n\nThe investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.', 'detailedDescription': 'Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion criteria will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week randomized control exercise intervention, baseline measures will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for type 2 diabetes :\n\n* Diagnosis of type 2 diabetes\n* Sedentary or minimally physically active for at least the prior 1 year\n* Able to give consent\n\nInclusion criteria for healthy control group:\n\n* Sedentary or minimally physically active for at least the prior 1 year\n* Able to give consent\n\nExclusion Criteria:\n\n* History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy\n* History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)\n* Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)\n* History of renal impairment\n* History of gout or hyperuricemia\n* History of hepatic disease or infection with hepatitis B, C\n* History of seizures, or other relevant on-going or recurrent illness\n* Recent (within 3 months) or recurrent hospitalizations\n* Use of tobacco products\n* \\>5 % weight change in the prior 6 months.\n* Current intake of medications that may affect study results\n* Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.\n* Pregnancy (positive urine pregnancy test) or lactation\n* For the healthy control group, history of diabetes.'}, 'identificationModule': {'nctId': 'NCT01883258', 'briefTitle': 'Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IRB201601534-N'}, 'secondaryIdInfos': [{'id': '280-2012', 'type': 'OTHER', 'domain': 'Legacy study'}, {'id': '1R21AG050203-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AG050203-01', 'type': 'NIH'}, {'id': 'OCR12584', 'type': 'OTHER', 'domain': 'University of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity aerobic interval training', 'description': 'Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.', 'interventionNames': ['Other: High intensity aerobic interval training']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous moderate intensity exercise', 'description': 'Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.', 'interventionNames': ['Other: Continuous moderate intensity exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Non-exercise control group', 'description': 'Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.'}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control group', 'description': 'Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.'}], 'interventions': [{'name': 'High intensity aerobic interval training', 'type': 'OTHER', 'description': 'Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.', 'armGroupLabels': ['High intensity aerobic interval training']}, {'name': 'Continuous moderate intensity exercise', 'type': 'OTHER', 'description': 'Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.', 'armGroupLabels': ['Continuous moderate intensity exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Demetra D Christou, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}