Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466713
Status:
TERMINATED
Last Update Posted:
2014-05-13
First Post:
2007-04-25
Brief Title:
Defining the Role of Insulin Resistance in Idiopathic Dilated Cardiomyopathy
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Defining the Role of Insulin Resistance in Idiopathic Dilated Cardiomyopathy
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
concern over safety of rosiglitazone in heart failure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the effects of rosiglitazone a medicine commonly used to treat type 2 diabetes on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the hearts ability to metabolize glucose sugar
Detailed Description:
Nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment HOMA value are eligible for the trial At baseline a 6-minute walk test is performed followed by assessment of coronary flow reserve with ammonia-PET imaging beforeafter adenosine infusion Subjects are then given an oral glucose load 75g followed by PET imaging with F-18-fluoro-2-deoxyglucose FDG Subjects then begin taking rosiglitazone 4 mg qd x 12 weeks after which the 6-minute walk test PET imaging is repeated
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