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Completed

NCT Number: NCT01574820

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

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.

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Key information

Conditions

PreDiabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Heart Diseases Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Prediabetic State Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Tablet

Drug

placebo tablet for 6 months

rosiglitazone (4 mg)/day

Drug

rosiglitazone (4 mg)/day for 6 months

Primary outcomes

  1. major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD

    Time frame: 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 outcomes

  1. Biomarkers measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Apr 10, 2012
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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