NCT01098045|Completed
HIV Fat Redistribution and the Evaluation of Brown Fat
FDG/PET Imaging for the Assessment of Brown Adipose Tissue in HIV Lipodystrophy
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FDG/PET Imaging for the Assessment of Brown Adipose Tissue in HIV Lipodystrophy
Sponsor study identifier
observational
27
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
August 2015
Actual (reported)The specific aims of this study are to determine whether HIV-infected patients with significant fat redistribution and ectopic fat accumulation have increased brown adipose tissue using 18F-FDG Positron Emission Tomography techniques. Recent studies suggest down regulation of Dicer, a major component of miRNA has an important role in the differentiation and function of brown and white adipose tissue and may contribute to lipodystrophy. Therefore we will expand on recent research in this area by recruiting HIV-infected men with lipodystrophy. We will perform subcutaneous fat biopsies of the dorsocervical and abdominal fat in a subset of HIV-infected and non-HIV-infected men in order to explore further the question of down regulation of Dicer and its implication on metabolic abnormalities in this population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
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.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 25, 2010
Actual (reported)April 2, 2010
Actual (reported)June 2014
Actual (reported)August 2015
Actual (reported)Brown Fat
Brown Fat will be assessed by PET FDG
Baseline
UCP-1
Baseline
Indirect Calorimetry
Baseline
Anthropometrics
Baseline
Glucose tolerance
Baseline
miRNAs
Baseline
1. Evidence of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 18-24 kg/m2 4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for \> 12 months 5. No evidence of fat redistribution rated by the investigator.
1. No history of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 18-29.9 kg/m2
1. Evidence of HIV infection 2. Age ≥ 20 and ≤ 60 years of age 3. BMI measurement between 25-29.9 kg/m2 4. HIV positive, on a stable HAART treatment regimen (including an NRTI) for \> 12 months 5. Evidence of significant fat redistribution rated by the investigator, including 1) significant fat atrophy of the face, arms or legs, and 2) significant increase in fat accumulation of the neck.
30 men \[HV-infected with fat redistribution (n = 10), HIV-infected without fat redistribution (n=10), and healthy controls (n= 10)\] will be recruited for this group.
HIV infected patients with fat redistribution and non HIV controls
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mallon PW, Miller J, Cooper DA, Carr A. Prospective evaluation of the effects of antiretroviral therapy on body composition in HIV-1-infected men starting therapy. AIDS. 2003 May 2;17(7):971-9. doi: 10.1097/00002030-200305020-00005.
Bernasconi E, Boubaker K, Junghans C, Flepp M, Furrer HJ, Haensel A, Hirschel B, Boggian K, Chave JP, Opravil M, Weber R, Rickenbach M, Telenti A; Swiss HIV Cohort Study. Abnormalities of body fat distribution in HIV-infected persons treated with antiretroviral drugs: The Swiss HIV Cohort Study. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):50-5. doi: 10.1097/00126334-200209010-00007.
Blood tests will include a complete blood count, creatinine, SGPT TSH and Free T4, triglyceride, total, HDL and LDL cholesterol, HIV test, CD4 count (for HIV+ subjects only), HIV viral load (for HIV+ subjects only), fasting glucose, 2 hour OGTT, as well as tissue samples from fat biopsy.
Steven Grinspoon, MD
Massachusetts General Hospital
Martin Torriani, MD
Massachusetts General Hopsital
27 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2010
First Posted
April 2, 2010
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
HIV and Fat Accumulation
Contact the study team to confirm eligibility.
Lichtenstein KA, Ward DJ, Moorman AC, Delaney KM, Young B, Palella FJ Jr, Rhodes PH, Wood KC, Holmberg SD; HIV Outpatient Study Investigators. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS. 2001 Jul 27;15(11):1389-98. doi: 10.1097/00002030-200107270-00008.
Miller J, Carr A, Emery S, Law M, Mallal S, Baker D, Smith D, Kaldor J, Cooper DA. HIV lipodystrophy: prevalence, severity and correlates of risk in Australia. HIV Med. 2003 Jul;4(3):293-301. doi: 10.1046/j.1468-1293.2003.00159.x.
Friis-Moller N, Weber R, Reiss P, Thiebaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93. doi: 10.1097/01.aids.0000060358.78202.c1.
Riddler SA, Smit E, Cole SR, Li R, Chmiel JS, Dobs A, Palella F, Visscher B, Evans R, Kingsley LA. Impact of HIV infection and HAART on serum lipids in men. JAMA. 2003 Jun 11;289(22):2978-82. doi: 10.1001/jama.289.22.2978.
Hadigan C, Meigs JB, Corcoran C, Rietschel P, Piecuch S, Basgoz N, Davis B, Sax P, Stanley T, Wilson PW, D'Agostino RB, Grinspoon S. Metabolic abnormalities and cardiovascular disease risk factors in adults with human immunodeficiency virus infection and lipodystrophy. Clin Infect Dis. 2001 Jan;32(1):130-9. doi: 10.1086/317541. Epub 2000 Dec 15.
Srinivasa S, Torriani M, Fitch KV, Maehler P, Iyengar S, Feldpausch M, Cypess AM, Grinspoon SK. Brief Report: Adipogenic Expression of Brown Fat Genes in HIV and HIV-Related Parameters. J Acquir Immune Defic Syndr. 2019 Dec 15;82(5):491-495. doi: 10.1097/QAI.0000000000002180.
Torriani M, Srinivasa S, Fitch KV, Thomou T, Wong K, Petrow E, Kahn CR, Cypess AM, Grinspoon SK. Dysfunctional Subcutaneous Fat With Reduced Dicer and Brown Adipose Tissue Gene Expression in HIV-Infected Patients. J Clin Endocrinol Metab. 2016 Mar;101(3):1225-34. doi: 10.1210/jc.2015-3993. Epub 2016 Jan 12.
Torriani M, Zanni MV, Fitch K, Stavrou E, Bredella MA, Lim R, Cypess AM, Grinspoon S. Increased FDG uptake in association with reduced extremity fat in HIV patients. Antivir Ther. 2013;18(2):243-8. doi: 10.3851/IMP2420. Epub 2012 Oct 5.
Primary Completion
June 2014
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
August 16, 2021
Record last verified: 2021-08
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