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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Active, not recruiting
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Beth Israel Deaconess Medical Center Identifier:
First received: August 30, 2005
Last updated: January 27, 2011
Last verified: January 2011
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
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

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • serum lipid levels

Secondary Outcome Measures:
  • 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
Detailed 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00140244

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00140244     History of Changes
Other Study ID Numbers: 2001-P-000484
Study First Received: August 30, 2005
Last Updated: January 27, 2011

Keywords provided by Beth Israel Deaconess Medical Center:
insulin resistance
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders processed this record on March 23, 2017