Phase 4
N=150
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00424762 ↗Enrolled (actual)
150
Serious AEs
3.3%
Results posted
Mar 2012
Primary outcome: Primary: Peak Oxygen Uptake (VO2) — 26.1; 27.6 ml O2 uptake/kg fat-free mass/minute — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rosiglitazone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Oxygen Uptake (VO2) |
26.1; 27.6 | 0.26 |
| SECONDARY Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months |
0.9; 0.85 | >0.05 |
| SECONDARY Percentage of Patients Developing New or Worsening Peripheral Edema |
54; 33 | 0.03 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00424762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.