Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HAART-induced Lipodystrophy and Metabolic Syndrome |
Drug: r-metHuLeptin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients |
- serum lipid levels
- insulin resistance (as assessed by the Boost challenge test and Galvin's index)
- glycemia
- apolipoprotein levels and LDL particle size
- FFA levels
- blood pressure
- thrombotic factors
- hormone levels
- body composition
- viral load
- lymphocyte subsets
- cytokine levels
- hepatic and abdominal fat content.
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | July 2003 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided by Beth Israel Deaconess Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00140244 History of Changes |
| Other Study ID Numbers: | 2001-P-000484 |
| Study First Received: | August 30, 2005 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beth Israel Deaconess Medical Center:
|
leptin lipodystrophy insulin resistance hyperlipidemia metabolic syndrome |
Additional relevant MeSH terms:
|
Lipodystrophy Metabolic Syndrome X Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders |
Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |
ClinicalTrials.gov processed this record on March 03, 2013
