Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
|ClinicalTrials.gov Identifier: NCT01574820|
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 11, 2012
The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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.