Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT01310556
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2011-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unknown Glucose Metabolism Disorders In Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-17', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of unknown glucose metabolism disorders in patients with coronary artery disease', 'timeFrame': '1 year', 'description': 'Results: While GMDs were detected in 58.26% (n=134 patients) of CAD patients, 41.74% of them (n=96 patients) were found to have normal glucose metabolism.'}], 'secondaryOutcomes': [{'measure': "Fasting and 120 minute glucose levels have relation with vessels' stenosis.", 'timeFrame': '1 year', 'description': 'Fasting glucose level was found to have a significant correlation with the total number of stenotic coronary vessels (p=0.0001) and the stenosis rate of all vessels . OGTT 120-minute glucose levels were found to have a significant correlation with the total number of stenotic coronary vessels and the stenosis rate of vessels with the exception of LAD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OGTT', 'coronary artery disease'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD).', 'detailedDescription': 'Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary artery disease and the relationship between different GMDs and CAD.\n\nSettings: 230 patients with coronary artery disease and without any known GMDs were included the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g Oral Glucose Tolerance Test (OGTT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with coronary artery disease and who had no glucose metabolism disorders.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary artery disease and who had no glucose metabolism disorders were included to study.\n\nExclusion Criteria:\n\n* Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT01310556', 'briefTitle': 'Unknown Glucose Metabolism Disorders In Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'The Relationship Between Previously Unknown Glucose Metabolism Disorders and Coronary Artery Disease in Patients Suffering From Coronary Artery Disease', 'orgStudyIdInfo': {'id': '12.05.2009-131-1068'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary artery disease', 'description': 'patients with coronary artery disease', 'interventionNames': ['Other: ogtt for patients with coronary artery disease']}], 'interventions': [{'name': 'ogtt for patients with coronary artery disease', 'type': 'OTHER', 'otherNames': ['no name'], 'description': '75 g OGTT', 'armGroupLabels': ['coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Aydogan Aydogdu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gulhane School of Medicine Ankara/Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gulhane School of Medicine', 'oldOrganization': 'Dep. of Endocrinology and Metabolism'}}}}