Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-02-02 @ 1:51 PM
Study NCT ID:
NCT02122835
Status:
WITHDRAWN
Last Update Posted:
2023-06-15
First Post:
2014-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise, Heart Failure, and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding/patient availability', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2014-04-18', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity', 'timeFrame': 'baseline, 12 weeks', 'description': 'measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness'}], 'secondaryOutcomes': [{'measure': 'flow-mediated dilation', 'timeFrame': 'baseline, 12 weeks', 'description': 'brachial artery flow-mediated dilation'}, {'measure': 'nitrite flux during exercise', 'timeFrame': 'baseline, 12 weeks', 'description': 'changes in plasma nitrite during exercise'}]}, 'conditionsModule': {'keywords': ['exercise', 'aerobic exercise'], 'conditions': ['Heart Failure', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.', 'detailedDescription': 'The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥50 yr of age\n* New York Heart Association class II-III CHF and ejection fraction ≤35%\n* receiving optimal medical therapy\n* sedentary (≤ 30 min/wk structured physical activity).\n* Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).\n\nExclusion Criteria:\n\n* smoking\n* changes in medication ≤6 wk prior to enrollment\n* major cardiovascular event or procedure ≤6 wk prior to enrollment\n* foot ulcers\n* advanced neuropathy\n* co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training\n* fixed rate pacemaker\n* type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02122835', 'briefTitle': 'Exercise, Heart Failure, and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'Pro00032063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'heart failure', 'description': 'aerobic exercise training', 'interventionNames': ['Behavioral: aerobic exercise training']}, {'type': 'OTHER', 'label': 'heart failure plus type 2 diabetes', 'description': 'aerobic exercise training', 'interventionNames': ['Behavioral: aerobic exercise training']}], 'interventions': [{'name': 'aerobic exercise training', 'type': 'BEHAVIORAL', 'description': '12 weeks of supervised aerobic exercise training', 'armGroupLabels': ['heart failure', 'heart failure plus type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'William Kraus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}