Overview

This trial is active, not recruiting.

Condition haart-induced lipodystrophy and metabolic syndrome
Treatment r-methuleptin
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date December 2001
End date July 2003
Trial size 15 participants
Trial identifier NCT00140244, 2001-P-000484

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
serum lipid levels
time frame:

Secondary Outcomes

Measure
insulin resistance (as assessed by the Boost challenge test and Galvin's index)
time frame:
glycemia
time frame:
apolipoprotein levels and LDL particle size
time frame:
FFA levels
time frame:
blood pressure
time frame:
thrombotic factors
time frame:
hormone levels
time frame:
body composition
time frame:
viral load
time frame:
lymphocyte subsets
time frame:
cytokine levels
time frame:
hepatic and abdominal fat content.
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - At least 18 years old - Documented HIV infection - Exposed to at least 6 months of cumulative highly active antiretroviral medications for HIV - Developed fat depletion after starting HIV medications - Low leptin level in the blood - Fasting triglyceride level > 300 mg/dl Exclusion Criteria: - Active infectious diseases, except HIV - Diabetes prior to starting HIV medications - Alcohol or drug abuse - Triglyceride level > 1000 mg/dl - Significant kidney, liver, or thyroid dysfunction - Cancer or lymphoma - Pregnancy or planning to become pregnant during the study

Additional Information

Official title Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.