NCT01574820

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Prediabetes
• Coronary Artery Disease
• Insulin Resistance
• Glucose Intolerance

Interventions

Type	Name	Description
DRUG	placebo tablet	placebo tablet for 6 months
DRUG	rosiglitazone (4 mg)/day	rosiglitazone (4 mg)/day for 6 months

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-08-01
• Completion: 2011-07-01
• First posted: 2012-04-10
• Last updated: 2012-04-11