| Trial ID: | L2082 |
| Source ID: | NCT01574820
|
| Associated Drug: |
Placebo Tablet
|
| Title: |
Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Prediabetes|Coronary Artery Disease|Insulin Resistance|Glucose Intolerance
|
| Interventions: |
DRUG: placebo tablet|DRUG: rosiglitazone (4 mg)/day
|
| Outcome Measures: |
Primary: major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD, Primary end points: The primary end-point was defined as major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD., at least 6 months follow-up of MACEs | Secondary: Biomarkers measurements, Resistin and adiponectin will be measured to evaluate insulin resistance; CCL/MCP-1 and hsCRP were also analyzed to evaluate inflammation status changes. Several vascular associated remodeling markers and proteins will also be measured., Biomarkers were taken before the trial and 6 months later
|
| Sponsor/Collaborators: |
Sponsor: National Cheng-Kung University Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-11
|
| Completion Date: |
2011-07
|
| Results First Posted: |
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| Last Update Posted: |
2012-04-11
|
| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT01574820
|
