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

National Cheng-Kung University

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Prediabetes; Insulin Resistance; Glucose Intolerance

Treatments: Drug: placebo tablet; Drug: rosiglitazone (4 mg)/day

Study type: Interventional

Funder types: Other

Identifiers

NCT01574820

NCKUH HR95-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo tablet

rosiglitazone (4 mg)/day

Experimental group

Treatment:

Drug: rosiglitazone (4 mg)/day