Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Beth Israel Deaconess Medical Center

Collaborator
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
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

More Information

Additional Information:

Click here for more information about the Mantzoros Research Group.

Additional Information:

Click here for more information about Beth Israel Deaconess Medical Center.

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  
Study First Received: August 30, 2005  
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

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.