NCT00636142

Effects of Infliximab on Insulin Sensitivity and Beta Cell Function in Insulin Resistant Human Obesity

A Prospective Trial of Anti-TNF-Alpha Chimeric Monoclonal Antibody (Infliximab, Remicade®) on Insulin Sensitivity, Beta Cell Function and Cardiovascular Risk Profile in Insulin Resistant Human Obesity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in obese male subjects.

Detailed description

Overweight and obesity are rapidly becoming one of the most pressing health problems. Obese subjects face an increased risk for cardiovascular events that is closely related to a cluster of metabolic disturbances (i.e. insulin resistance, hypertension, dyslipidemia and impaired fibrinolysis), collectively referred to as syndrome X. The actual mechanism underlying development of syndrome X has not been elucidated. Increased TNF-alpha activity has been proposed as a key factor. The objectives of the study are to test whether neutralizing TNF-alpha with infliximab in obese subjects affects insulin resistance and phenotypical manifestations of the metabolic syndrome such as: * fasting plasma insulin * ivGTT derived parameters of insulin resistance and beta-cell function * total body fat * plasma lipid profile * vascular endothelial dysfunction

Conditions

• Obesity
• Insulin Resistance
• Metabolic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Infliximab	5 mg/kg body weight, maximal dose 500 mg; intravenous administration

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-06-01
• Completion: 2007-09-01
• First posted: 2008-03-14
• Last updated: 2008-03-14

Locations

1 site across 1 country: Austria