Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to determine if rosiglitazone treatment improves integrated cardiovascular performance in patients at risk for congestive heart failure. A second aim of this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic) triglyceride (TG) deposition in cardiomyocytes using nuclear magnetic resonance (NMR) techniques, and how changes in intra-myocardial lipid content relate to changes in cardiac structure and function.

Key facts

Study ID

NCT00424762

Run by

University of Texas Southwestern Medical Center

People needed

150

Starts

2005-02-01

Expected to finish

2007-04-01

Last updated by the study team

2012-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• type 2 diabetes mellitus (prior clinical diagnosis and current use of hypoglycemic medical therapy or by new diagnosis according to ADA criteria) with at least one of the following:
• prior diagnosis of cardiovascular disease (CAD, MI, revascularization, CVA/TIA, carotid or peripheral arterial disease)
• at least one additional CVD risk factor (smoking, hypertension, hypercholesterolemia, albuminuria, family history of premature CAD, or documented hsCRP>3)

You may not qualify if…

• treatment with a TZD within prior 6 months
• documented intolerance to TZD
• history or evidence of CHF
• AST/ALT>3X upper limits of normal
• creatinine >2.5

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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