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NCT00140244·Phase 2·INTERVENTIONAL

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

MetreleptinOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

7

Locations

1

Results

Posted

Publications

2

Study summary

What the protocol is testing.

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.

Full 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

Interventions

Treatment arms and agents.

DRUG

r-metHuLeptin

DRUG

Placebo

Timeline

From registration to results.

  1. First posted

    Sep 1, 2005

  2. Study start

    Dec 2001

  3. Primary completion

    Jun 2011

  4. Study completion

    Jun 2011

  5. Results posted

    Apr 6, 2017

  6. Registry updated

    May 11, 2017

Outcomes

What the study measures.

Primary outcomes

Serum Lipid Levels

Time frame · At the end of each two month intervention

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Publications

Results and literature.

PMID 35820631 ↗Bouzoni E, Perakakis N, Connelly MA, Angelidi AM, Pilitsi E, Farr O, Stefanakis K, Mantzoros CS. PCSK9 and ANGPTL3 levels correlate with hyperlipidemia in HIV-lipoatrophy, are regulated by fasting and are not affected by leptin administered in physiologic or pharmacologic doses. Metabolism. 2022 Sep;134:155265. doi: 10.1016/j.metabol.2022.155265. Epub 2022 Jul 9.PMID 21081243 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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