| Trial ID: | L5902 |
| Source ID: | NCT00424762
|
| Associated Drug: |
Rosiglitazone
|
| Title: |
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00424762/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: rosiglitazone|DRUG: placebo
|
| Outcome Measures: |
Primary: Peak Oxygen Uptake (VO2), measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute, 6 months | Secondary: Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months, proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%), 6 months|Percentage of Patients Developing New or Worsening Peripheral Edema, clinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline, 6 months
|
| Sponsor/Collaborators: |
Sponsor: University of Texas Southwestern Medical Center | Collaborators: GlaxoSmithKline|Abbott RDx Cardiometabolic
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-02
|
| Completion Date: |
2007-04
|
| Results First Posted: |
2012-03-30
|
| Last Update Posted: |
2012-04-04
|
| Locations: |
University of Texas Southwestern Medical Center, Dallas, Texas, 75390-9034, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00424762
|
