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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01574820

Enrollment

105

Registered

2012-04-10

Start date

2006-11-30

Completion date

2011-07-31

Last updated

2012-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Glucose Intolerance, Insulin Resistance, Prediabetes

Keywords

prediabetes, coronary artery disease, insulin resistance, glucose intolerance

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.

Interventions

DRUGplacebo tablet

placebo tablet for 6 months

DRUGrosiglitazone (4 mg)/day

rosiglitazone (4 mg)/day for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026