Sponsor study identifier
Secondary identifiers
NIH
interventional
7
1 country
1
Study Start
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
August 30, 2005
Actual (reported)September 1, 2005
Actual (reported)June 2011
Actual (reported)June 2011
Actual (reported)April 6, 2017
Actual (reported)Serum Lipid Levels
At the end of each two month intervention
Insulin Resistance (as Assessed by HOMA-IR)
At the end of each two month intervention
Glycemia (as Assessed by Fasting Glucose)
At the end of each two month intervention
Low Density Lipoprotein (LDL) Cholesterol Levels
At the end of each two month intervention
Free Fatty Acid (FFA) Levels
At the end of each two month intervention
Blood Pressure
At the end of each two month intervention
r-MetHuLeptin SubQ once daily
SubQ once daily
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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.
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.
7 participants (actual enrollment reported by the registry).
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
December 2001
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
May 11, 2017
Results First Posted
April 6, 2017
Record last verified: 2017-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: