Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01574820
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2012-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
Sponsor:
National Cheng-Kung University Hospital
Organization:
Study Overview
Official Title:
Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: