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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Amgen
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00140244
First received: August 30, 2005
Last updated: January 27, 2011
Last verified: January 2011
  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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140244

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Amgen
  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 July 29, 2014