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Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride

NCT00424762 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-04-04

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

rosiglitazone

6 months of treatment of blinded study drug

DRUG

placebo

blinded treatment with matching placebo

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Abbott RDx Cardiometabolic

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Darren K McGuire, MD, MHSc · University of Texas Southwestern Medical Center

  • Darren K McGuire, M.D., MHSc · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424762 on ClinicalTrials.gov