Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:11 PM
Study NCT ID:
NCT01232608
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2010-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular 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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2010-10-25', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucometabolic state', 'timeFrame': '12 months', 'description': 'Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose'}, {'measure': 'Atherosclerosis', 'timeFrame': '12 months', 'description': 'Atherosclerosis will be assessed by measurements of:\n\n* Carotid intima-media thickness (IMT)\n* Biomarkers of inflammation, haemostasis and endothelial function'}], 'secondaryOutcomes': [{'measure': 'Dyslipidemia', 'timeFrame': '12 months', 'description': 'Dyslipidemia will be measured by total cholesterol, HDL, LDL, fasting triglycerides and free fatty acids'}, {'measure': 'Visceral obesity', 'timeFrame': '12 months', 'description': 'Visceral obesity will be measured by waist circumference'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Atherosclerosis.', 'Diabetes Mellitus, type 2', 'Exercise', 'HbA1c', 'Carotid Atherosclerotic Disease', 'Inflammation'], 'conditions': ['Coronary Artery Disease', 'Diabetes Mellitus, Type 2', 'Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '34779349', 'type': 'DERIVED', 'citation': 'Zaidi H, Byrkjeland R, Njerve IU, Akra S, Solheim S, Arnesen H, Seljeflot I, Opstad TB. Adiponectin in relation to exercise and physical performance in patients with type 2 diabetes and coronary artery disease. Adipocyte. 2021 Dec;10(1):612-620. doi: 10.1080/21623945.2021.1996699.'}, {'pmid': '33794977', 'type': 'DERIVED', 'citation': 'Aune SK, Byrkjeland R, Solheim S, Arnesen H, Troseid M, Awoyemi A, Seljeflot I, Helseth R. Gut related inflammation and cardiorespiratory fitness in patients with CAD and type 2 diabetes: a sub-study of a randomized controlled trial on exercise training. Diabetol Metab Syndr. 2021 Apr 1;13(1):36. doi: 10.1186/s13098-021-00655-2.'}, {'pmid': '31890043', 'type': 'DERIVED', 'citation': 'Zaidi H, Byrkjeland R, Njerve IU, Akra S, Solheim S, Arnesen H, Seljeflot I, Opstad TB. Effects of exercise training on markers of adipose tissue remodeling in patients with coronary artery disease and type 2 diabetes mellitus: sub study of the randomized controlled EXCADI trial. Diabetol Metab Syndr. 2019 Dec 19;11:109. doi: 10.1186/s13098-019-0508-9. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular disease, and people with type 2 diabetes have a two- to four-fold increased risk for cardiovascular morbidity and mortality. Physical activity is a well established therapeutic modality for type 2 diabetes. In patients with coronary artery disease (CAD), several clinical trials have shown reduced mortality and reduced progression of atherosclerosis with lifestyle intervention including physical activity. But few studies have investigated the effect of physical training in patients suffering from both diseases.\n\nThe aim of this study is to investigate the effect of one year of organized physical exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and progression of atherosclerosis.\n\nThe project is a randomized, controlled, open study on physical exercise. 136 patients will be randomized at inclusion to a physical exercise group or a control group, the latter with "normal" follow-up and not discouraged form physical activity. The intervention period will be 12 months, and the physical training program will be developed and conducted in collaboration with Norwegian School of Sport Sciences. The inclusion of patients started summer 2010, the exercise program begins in September 2010 and the practical issues of the study is planned to end during spring 2012.\n\nThe main hypothesis is that physical exercise improves the glucometabolic state and reduces progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes, and secondary that physical exercise induces favourable changes in cardiovascular risk factors, use of medication, and co-morbidity associated with diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary artery disease\n* type 2 diabetes\n\nExclusion Criteria:\n\n* serious diabetic retinopathy, nephropathy and/ or neuropathy\n* other serious diseases like cancer, stroke or MI last three months, unstable angina, decompensated heart failure, serious ventricular arrhythmia, aortic aneurism, serious valvular heart disease, chronic obstructive pulmonary disease GOLD classification IV, deep venous/ pulmonary embolism, ongoing infections, serious musculoskeletal disorders.\n* other serious limitations to physical exercise\n* pathological exercise stress test warranting further cardiovascular examination'}, 'identificationModule': {'nctId': 'NCT01232608', 'acronym': 'EXCADI', 'briefTitle': 'Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2010/1060-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': '12 months of exercise training', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Normal follow-up by primary physician'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '12 months of exercise training', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Ingebjørg Seljeflot, phd professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}