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

April 10, 2012 updated by: National Cheng-Kung University Hospital

Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo tablet
placebo tablet for 6 months
Experimental: rosiglitazone (4 mg)/day
Drug: rosiglitazone (4 mg)/day
rosiglitazone (4 mg)/day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at least 6 months follow-up of MACEs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Biomarkers were taken before the trial and 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 7, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKUH HR95-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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