Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease

Study Overview
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Brief Summary
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Objectives: The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD). Background: Microvascular and macrovascular complications are common in type 2 DM. There is no evidence about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory process activators) on pre-DM patients with documented CAD.

Detailed Description
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Materials and Methods: This is a randomized, double-blind, placebo-controlled study, patients will be randomly assigned to the TZD group and to the placebo group with a 6-month treatment period. Biomarkers will also examined before and 6 months post-treatment during the trial. The primary end-points will be the diagnosis of major cardiovascular events: myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.

Official Title
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Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease

Conditions
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Prediabetes, Coronary Artery Disease, Insulin Resistance, Glucose Intolerance

Intervention / Treatment
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* Drug: placebo tablet
* Drug: rosiglitazone (4 mg)/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented CAD by angiography insulin resistance or glucose intolerance 18 to 80 years of age Exclusion Criteria: under DM treatment allergy to TZD active inflammation chronic disease under NSAID treatment active heart failure unwilling or unable to sign inform consents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo tablet<br>* placebo tablet for 6 months<br>|
| Experimental: rosiglitazone (4 mg)/day<br> | Drug: rosiglitazone (4 mg)/day<br>* rosiglitazone (4 mg)/day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prediabetes, coronary artery disease, insulin resistance, glucose intolerance