Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-04 @ 9:00 AM
Study NCT ID:
NCT00510705
Status:
TERMINATED
Last Update Posted:
2020-11-27
First Post:
2007-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2007-08-01', 'studyFirstSubmitQcDate': '2007-08-01', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in endothelial function in severe coronary artery disease', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'change in metabolic parameters', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'keywords': ['adiposity'], 'conditions': ['Severe Coronary Artery Disease', 'Obesity', 'Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either impaired glucose tolerance (2 hour plasma glucose concentration \\> 7.8 and \\< 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( \\> 6.0 and \\< 7.0 mmol/L)\n* Body mass index (BMI) \\> 25\n* Severe coronary artery disease determined by coronary angiography\n* Male patients aged 35-75 years\n\nExclusion Criteria:\n\n* Diabetes mellitus type I\n* Diabetes mellitus type II in combination with glycosylates hemoglobin \\> 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \\> 11.0 mmol/L\n* Unstable angina pectoris\n* Myocardial infarction within the last 4 weeks\n* Reduced left-ventricular systolic function \\< 30%'}, 'identificationModule': {'nctId': 'NCT00510705', 'acronym': 'KFO', 'briefTitle': 'Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'orgStudyIdInfo': {'id': '0816-2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Regular physical exercise training alone', 'interventionNames': ['Other: exercise training']}, {'type': 'OTHER', 'label': '2', 'description': 'Regular physical exercise training + metformin', 'interventionNames': ['Other: exercise training + metformin']}, {'type': 'OTHER', 'label': '3', 'description': 'Regular physical exercise training + glitazone', 'interventionNames': ['Other: exercise training + glitazone']}, {'type': 'NO_INTERVENTION', 'label': '4', 'description': 'Control'}], 'interventions': [{'name': 'exercise training', 'type': 'OTHER', 'description': 'physical exercise training on a bicycle ergometer daily for 4 weeks', 'armGroupLabels': ['1']}, {'name': 'exercise training + metformin', 'type': 'OTHER', 'description': 'physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks', 'armGroupLabels': ['2']}, {'name': 'exercise training + glitazone', 'type': 'OTHER', 'description': 'physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig - Heart Center', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Gerhard Schuler, Prof. of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Leipzig - University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Investigator', 'investigatorFullName': 'Axel Linke', 'investigatorAffiliation': 'University of Leipzig'}}}}