Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368017
Status:
TERMINATED
Last Update Posted:
2010-11-03
First Post:
2006-08-23
Brief Title:
Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Metabolic Effects of Thiazolidinediones in Chronic Kidney Disease
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to replace Fellow conducting the study who left institution in 2007
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease CKD patients cannot be sufficiently explained by traditional coronary risk factors It is apparent that inflammation of the vessel wall plays an essential role in the pathophysiology of atherosclerosis and the strong association between elevated inflammatory biomarkers and cardiovascular death further supports this mechanism Approximately 50 of the mortality in this population of patients is attributable to cardiovascular disease Insulin resistance is also a common problem in uremic patients It has been shown that insulin resistance may contribute to atherosclerotic cardiovascular disease An intriguing observation in CKD patients with advanced uremia is that the metabolic profile of these patients is characterized by persistent low-grade inflammation a state of insulin resistance and significantly increased prevalence of atherosclerosis It is possible that these metabolic derangements can be the inciting factors for development and progression of uremic atherosclerosis Peroxisome proliferator-activated receptor gamma PPAR-gamma is a ligand-activated nuclear transcription factor found in cells of the immune system and the vasculature where it exerts an overall protective effect on the development of atherosclerosis in part through modulation of inflammation The agonists for PPAR-gamma improve not only the insulin resistance but also have profound beneficial effects on inflammation oxidative stress endothelium and lipid metabolism In this proposal the investigators hypothesize that short-term administration of a PPAR-gamma agonist pioglitazone will improve the inflammatory state insulin resistance and endothelial dysfunction in chronic kidney disease patients with advanced uremia
Detailed Description:
None
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