Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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: February 22, 2017
Last verified: February 2017

August 30, 2005
February 22, 2017
December 2001
June 2011   (Final data collection date for primary outcome measure)
Serum Lipid Levels [ Time Frame: At the end of each two month intervention ]
Serum Lipid Levels
Complete list of historical versions of study NCT00140244 on ClinicalTrials.gov Archive Site
  • 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 ]
  • LDL Levels [ Time Frame: At the end of each two month intervention ]
  • 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 ]
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
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.

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

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
HAART-induced Lipodystrophy and Metabolic Syndrome
  • Drug: r-metHuLeptin
  • Drug: Placebo
  • Active Comparator: r-MetHuLeptin
    r-MetHuLeptin SubQ once daily
    Intervention: Drug: r-metHuLeptin
  • Placebo Comparator: Placebo
    SubQ once daily
    Intervention: Drug: Placebo
Magkos F, Brennan A, Sweeney L, Kang ES, Doweiko J, Karchmer AW, Mantzoros CS. Leptin replacement improves postprandial glycemia and insulin sensitivity in human immunodeficiency virus-infected lipoatrophic men treated with pioglitazone: a pilot study. Metabolism. 2011 Jul;60(7):1045-9. doi: 10.1016/j.metabol.2010.10.002. Epub 2010 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00140244
2001P000484
R01DK058785 ( US NIH Grant/Contract Award Number )
Not Provided
Not Provided
Not Provided
Not Provided
Christos Mantzoros, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Amgen
Not Provided
Beth Israel Deaconess Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP