Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424762
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2007-01-18
Brief Title:
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Effect of Rosiglitazone Versus Placebo on Cardiovascular Performance and Myocardial Triglyceride
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Cardiovascular disease CVD including congestive heart failure CHF accounts for over 75 of deaths among patients with diabetes Thus it is imperative to rigorously evaluate existing and emerging hypoglycemic therapies with regard to their cardiovascular consequences The thiazolidinedione TZD class of drugs alone or in combination with other oral hypoglycemic medications or with insulin has emerged as a safe and effective treatment of hyperglycemia in type 2 diabetes Both in vitro and in vivo studies have revealed favorable pleiotropic effects of TZD on myocyte and ventricular structure and function However approximately 10 of patients taking TZDs develop peripheral edema and some patients have developed heart failure decompensation on the drug These observations have led to a Food and Drug Administration FDA warning regarding the use of TZDs in patients with or at high risk of developing congestive heart failure CHF The exact effects of TZDs on integrated cardiovascular performance remain unclear The primary hypothesis of this study is that TZD treatment improves integrated cardiovascular performance in patients at risk for CHF by improving both central ie cardiac output and peripheral ie vascular resistance function
Recently we have developed a sensitive reproducible noninvasive assay to measure intra-cardiomyocyte fat which varies widely in amount between individuals The relationship between the amount of cardiomyocyte triglyceride accumulation and LV mass and function remains unclear TZDs have been previously shown to be associated with decreases in the TG content of the liver and muscle The secondary hypothesis being tested in this study is that TZD treatment improves cardiac function by decreasing intra-cardiac myocyte triglyceride content
Comparisons
Peak oxygen uptake VO2 during cardiopulmonary exercise testing in individuals randomized to rosiglitazone compared to those on placebo
Amount of intra-myocardial triglycerides using NMR techniques in in individuals randomized to rosiglitazone compared to those on placebo
Recently we have developed a sensitive reproducible noninvasive assay to measure intra-cardiomyocyte fat which varies widely in amount between individuals The relationship between the amount of cardiomyocyte triglyceride accumulation and LV mass and function remains unclear TZDs have been previously shown to be associated with decreases in the TG content of the liver and muscle The secondary hypothesis being tested in this study is that TZD treatment improves cardiac function by decreasing intra-cardiac myocyte triglyceride content
Comparisons
Peak oxygen uptake VO2 during cardiopulmonary exercise testing in individuals randomized to rosiglitazone compared to those on placebo
Amount of intra-myocardial triglycerides using NMR techniques in in individuals randomized to rosiglitazone compared to those on placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None