Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
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ClinicalTrials.gov Identifier: NCT01574820 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : April 11, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prediabetes Coronary Artery Disease Insulin Resistance Glucose Intolerance | Drug: placebo tablet Drug: rosiglitazone (4 mg)/day | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | July 2011 |

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 |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | National Cheng-Kung University Hospital |
ClinicalTrials.gov Identifier: | NCT01574820 |
Other Study ID Numbers: |
NCKUH HR95-10 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | April 11, 2012 |
Last Verified: | April 2012 |
prediabetes coronary artery disease insulin resistance glucose intolerance |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Insulin Resistance Prediabetic State Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hyperinsulinism Hyperglycemia Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |