Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300911
Status:
COMPLETED
Last Update Posted:
2006-03-10
First Post:
2006-03-09
Brief Title:
Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction
Sponsor:
Baskent University
Organization:
Baskent University
Study Overview
Official Title:
A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2005-11
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 present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin
Detailed Description:
Large scale clinical trials have reported fluid retention and increase in plasma volume 6 to 7 with glitazone therapy with an increased incidence of peripheral edema occuring in 2 to 5 patients Some evidence suggests that this effect may be related to increased endothelial cell permeability induced by glitazones therapy Others report that glitazones may interfere with renal hemodynamics In controlled clinical trials the frequency of new onset congestive heart failure was very low in glitazones treated patients The incidence of congestive heart failure is higher in patients receiving combination therapy with insulin and glitazones Only few studies compared rosiglitazone and metformin on cardiac safety Recently a study reported a reversible increase in endothelial cell permeability to albumin in cultured pulmonary arterial cells treated with rosiglitazone To our knowledge there is not any clinical study published for showing the reversibility of the cardiac adverse effects if the rosiglitazone treatment is continued
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