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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amgen
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00140244
First received: August 30, 2005
Last updated: April 6, 2017
Last verified: April 2017
  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 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 Christos Mantzoros, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Serum Lipid Levels [ Time Frame: At the end of each two month intervention ]

Secondary Outcome Measures:
  • Insulin Resistance (as Assessed by HOMA-IR) [ Time Frame: At the end of each two month intervention ]
  • Glycemia (as Assessed by Fasting Glucose) [ Time Frame: At the end of each two month intervention ]
  • Low Density Lipoprotein (LDL) Cholesterol Levels [ Time Frame: At the end of each two month intervention ]
  • Free Fatty Acid (FFA) Levels [ Time Frame: At the end of each two month intervention ]
  • Blood Pressure [ Time Frame: At the end of each two month intervention ]
    percent change in mean blood pressure

  • Fibrinogen [ Time Frame: At the end of each two month intervention ]
    Fibrinogen

  • Insulin Levels [ Time Frame: At the end of each two month intervention ]
  • Lean Body Mass [ Time Frame: At the end of each two month intervention ]
    lean body mass

  • Viral Load [ Time Frame: At the end of each two month intervention ]
  • CD4+ Lymphocytes [ Time Frame: At the end of each two month intervention ]
  • Interleukin-6 (IL-6) Levels [ Time Frame: At the end of each two month intervention ]
  • Hepatic Fat Content [ Time Frame: At the end of each two month intervention ]

Enrollment: 7
Study Start Date: December 2001
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: r-MetHuLeptin
r-MetHuLeptin SubQ once daily
Drug: r-metHuLeptin
Placebo Comparator: Placebo
SubQ once daily
Drug: Placebo

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140244     History of Changes
Other Study ID Numbers: 2001P000484
R01DK058785 ( U.S. NIH Grant/Contract )
Study First Received: August 30, 2005
Results First Received: December 22, 2015
Last Updated: April 6, 2017

Keywords provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:
leptin
lipodystrophy
insulin resistance
hyperlipidemia
metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Lipodystrophy
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on August 21, 2017