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

Phase 3

Completed

• Conditions: Prediabetes; Coronary Artery Disease; Insulin Resistance; Glucose Intolerance
• Interventions: Drug: placebo tablet; Drug: rosiglitazone (4 mg)/day

• Registration Number: NCT01574820
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2010-08
• Study Completion: 2011-07
• Status Verified: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-07
• Study First Posted: 2012-04-10
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo tablet	-
rosiglitazone (4 mg)/day	rosiglitazone (4 mg)/day	-

Primary Outcome Measures

Name	Time	Method
major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD	at least 6 months follow-up of MACEs	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.

Secondary Outcome Measures

Name	Time	Method
Biomarkers measurements	Biomarkers were taken before the trial and 6 months later	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.