Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409318
Status:
COMPLETED
Last Update Posted:
2008-05-28
First Post:
2006-12-07
Brief Title:
Study of TNF-Antagonism in Metabolic Syndrome
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Effects of TNF-Alpha Antagonism in Patients With the Metabolic Syndrome I
Status:
COMPLETED
Status Verified Date:
2008-05
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 investigates whether blockade of TNF will result in reduced inflammatory indices 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 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 but have not been examined in the metabolic syndrome population Moreover 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 We propose a study in which we administer etanercept a TNF-alpha receptor fusion protein to subjects with metabolic syndrome to examine its effect on inflammatory markersCRP adiponectin and insulin resistance This would be the first study to investigate the anti-inflammatory properties and insulin sensitizing potential of TNF-alpha blockade on the growing population with metabolic syndrome
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