Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479986
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2007-05-29
Brief Title:
Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease
Sponsor:
IKFE Institute for Clinical Research and Development
Organization:
IKFE Institute for Clinical Research and Development
Study Overview
Official Title:
Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications A Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2007-05
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:
PIOcard
Brief Summary:
The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone in comparison to placebo on biomarkers for atherosclerosis and cardiovascular risk as well as the degree of activation of the immune system when given on top of an anti-diabetic treatment metformin andor sulfonylurea drugs that has already resulted in good glycemic control
Detailed Description:
PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical assessement of intima-media-thickness or biochemical hsCRP MMP-9 etc markers Well controlled patients HbA1c 80 will receive either pioglitazone or placebo randomised double-blind for 4 weeks Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system which is another measure for the risk of atherosclerosis development
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