HAART-induced Lipodystrophy and Metabolic Syndrome Clinical Trial
Official title:
Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.
Exposure to HIV medications has been associated with metabolic changes including generalized
fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar
levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone
produced by fat cells. Recent studies involving leptin administration to patients with
congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as
insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced
lipoatrophy may also lead to significant improvements in the metabolic abnormalities found
in these HIV+ patients. The aims of this study are to examine the effect of leptin
administration on insulin resistance and other parameters of the metabolic syndrome in HIV
patients with HAART-induced lipoatrophy.
Comparison: Leptin-treated group to placebo-treated group
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment