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NCT00140244 Clinical Trial

Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00140244
Other study ID # 2001-P-000484
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received August 30, 2005
Last updated January 27, 2011
Start date December 2001
Est. completion date July 2003

Study information
Verified date January 2011
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• r-metHuLeptin

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Amgen, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum lipid levels
Secondary insulin resistance (as assessed by the Boost challenge test and Galvin's index)
Secondary glycemia
Secondary apolipoprotein levels and LDL particle size
Secondary FFA levels
Secondary blood pressure
Secondary thrombotic factors
Secondary hormone levels
Secondary body composition
Secondary viral load
Secondary lymphocyte subsets
Secondary cytokine levels
Secondary hepatic and abdominal fat content.

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