Obesity Clinical Trial
Official title:
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
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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