Ignite Creation Date:
2024-05-06 @ 12:26 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01574820
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2012-04-04
Brief Title:
Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
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:
None
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?:
None