Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 10:00 PM
Study NCT ID:
NCT00314561
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2006-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000077154', 'term': 'Rosiglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2006-04-12', 'studyFirstSubmitQcDate': '2006-04-12', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)'}], 'secondaryOutcomes': [{'measure': 'The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.'}]}, 'conditionsModule': {'keywords': ['Rosiglitazone', 'Pioglitazone', 'FMD', 'PWV', 'atherosclerosis'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol \\< 40 mg/dl for men and \\< 50 mg/dl for women.\n* Age: 18 years and above\n\nExclusion Criteria:\n\n* Hypertensive patients with the use of ACE inhibitor or ARB\n* Hyperlipidemic patients with the use of statin or fenofibrate\n* Patients with any contraindications to the treatment of thiazolidinediones\n* Pregnant or lactating patients\n* Chronic alcohol or drug abuse\n* Hepatic dysfunction\n* Renal dysfunction\n* Heart failure (EF \\< 50%)\n* Expected life expectancy of \\< 1 year'}, 'identificationModule': {'nctId': 'NCT00314561', 'briefTitle': 'The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome: A Prospective, Randomized, Open-label, Crossover Trial', 'orgStudyIdInfo': {'id': 'KoreaUAnanmH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pioglitazone, Rosiglitazone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong Sup Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}}}}