Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Feb 2005
Typical duration for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 18, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedResults Posted
Study results publicly available
March 30, 2012
CompletedApril 4, 2012
April 1, 2012
2.2 years
January 18, 2007
August 10, 2011
April 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months
6 months
Percentage of Patients Developing New or Worsening Peripheral Edema
6 months
Study Arms (2)
rosiglitazone
EXPERIMENTAL4mg titrated to 8mg daily
Placebo
PLACEBO COMPARATORblinded matching placebo treatment
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- GlaxoSmithKlinecollaborator
- Abbott RDx Cardiometaboliccollaborator
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9034, United States
Related Publications (5)
McGuire DK, See R, Abdullah SM, Snell PG, McGavock JM, Ayers CR, Szczepaniak LS. The effect of rosiglitazone on integrated cardiovascular performance, cardiac structure, function and myocardial triglyceride: trial design and rationale. Diab Vasc Dis Res. 2009 Jan;6(1):43-50. doi: 10.3132/dvdr.2009.009.
PMID: 19156629BACKGROUNDMcGuire DK, Abdullah SM, See R, Snell PG, McGavock J, Szczepaniak LS, Ayers CR, Drazner MH, Khera A, de Lemos JA. Randomized comparison of the effects of rosiglitazone vs. placebo on peak integrated cardiovascular performance, cardiac structure, and function. Eur Heart J. 2010 Sep;31(18):2262-70. doi: 10.1093/eurheartj/ehq228. Epub 2010 Jul 2.
PMID: 20601395RESULTJarvie JL, Pandey A, Ayers CR, McGavock JM, Senechal M, Berry JD, Patel KV, McGuire DK. Aerobic Fitness and Adherence to Guideline-Recommended Minimum Physical Activity Among Ambulatory Patients With Type 2 Diabetes Mellitus. Diabetes Care. 2019 Jul;42(7):1333-1339. doi: 10.2337/dc18-2634. Epub 2019 May 21.
PMID: 31221698DERIVEDMcGavock J, Szczepaniak LS, Ayers CR, Abdullah SM, See R, Gore MO, Drazner MH, de Lemos JA, McGuire DK. The effects of rosiglitazone on myocardial triglyceride content in patients with type 2 diabetes: a randomised, placebo-controlled trial. Diab Vasc Dis Res. 2012 Apr;9(2):131-7. doi: 10.1177/1479164111428628. Epub 2011 Nov 8.
PMID: 22067724DERIVEDNarang N, Armstead SI, Stream A, Abdullah SM, See R, Snell PG, McGavock J, Ayers CR, Gore MO, Khera A, de Lemos JA, McGuire DK. Assessment of cardiac structure and function in patients without and with peripheral oedema during rosiglitazone treatment. Diab Vasc Dis Res. 2011 Apr;8(2):101-8. doi: 10.1177/1479164111403334.
PMID: 21562061DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Larger than anticipated study discontinuation-72% with complete primary data analysis with lower numbers analyzed for imaging endpoints
Results Point of Contact
- Title
- Dr. Darren K. McGuire
- Organization
- University of Texas Southwestern Medical Center at Dallas
Study Officials
- PRINCIPAL INVESTIGATOR
Darren K McGuire, MD, MHSc
University of Texas Southwestern Medical Center
- STUDY CHAIR
Darren K McGuire, M.D., MHSc
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 18, 2007
First Posted
January 22, 2007
Study Start
February 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
April 4, 2012
Results First Posted
March 30, 2012
Record last verified: 2012-04