Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413400
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2006-12-07
Brief Title:
Study of TNF-Antagonism in the Metabolic Syndrome II
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Effects of Etanercept in Patients With the Metabolic Syndrome II
Status:
COMPLETED
Status Verified Date:
2010-11
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:
This study will investigate whether etanercept will result in improved inflammatory indices glucose tolerance and endothelial function in patients with the metabolic syndrome
Detailed Description:
Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM diabetes mellitus and cardiovascular morbidity and mortality A subclinical inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome insulin resistance and coronary artery disease CAD Tumor Necrosis Factor TNF -alpha is an inflammatory cytokine that is increased in a spectrum of inflammatory diseases as well as in insulin resistance TNF-alpha antagonists are clinically effective in the inflammation of arthritides and have recently been shown by our group to decrease inflammatory cardiovascular risk markers in metabolic syndrome Data suggests that adiponectin a recently discovered adipocytokine that may protect against the development of insulin resistance and atherosclerosis may be downregulated by TNF-alpha In addition population based studies have shown that those with the highest levels of TNF-alpha have an increased relative risk of cardiovascular morbidity while rheumatoid arthritis patients treated with TNF-alpha blockade appear protected from cardiovascular disease We will perform a 6-month study in which we will administer etanercept a TNF-alpha receptor fusion protein to subjects with metabolic syndrome to investigate its effect on surrogate markers of cardiovascular disease including inflammatory markers adiponectin and glucose tolerance and endothelial function The results of the proposed study will have broad implications regarding the physiological role of TNF-alpha on the inflammatory cascade cardiovascular indices and endothelial function
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