A Phase 3 interventional study of placebo tablet and rosiglitazone (4 mg)/day in Prediabetes, Coronary Artery Disease and Insulin Resistance, sponsored by National Cheng-Kung University Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-11.
Sponsored by National Cheng-Kung University Hospital · Phase 3, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 105 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
Drug: placebo tablet
Drug: rosiglitazone (4 mg)/day
placebo tablet for 6 months
rosiglitazone (4 mg)/day for 6 months
major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
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.
Time frame: at least 6 months follow-up of MACEs
Biomarkers measurements
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.
Time frame: Biomarkers were taken before the trial and 6 months later
No study locations are listed for this record.
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital