Observational Study of Changes in Fat Distribution and Blood Metabolites in HIV Infected Adults

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ClinicalTrials.gov Identifier: NCT00331448

Recruitment Status : Unknown

Verified May 2006 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was: Active, not recruiting

First Posted : May 31, 2006

Last Update Posted : August 15, 2006

Sponsor:

Collaborators:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Drug Abuse (NIDA)

NIH Office of AIDS Research (OAR)

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

Brief Summary:

The purpose of this study is to collect data on the body's breakdown of sugar and fat in HIV infected adults. Data from this study will make clearer the roles of HIV infection and anti-HIV drugs in the development of diabetes, heart disease, and fat redistribution in HIV infected adults.

Condition or disease
HIV Infections Lipodystrophy Diabetes Hyperlipidemia Atherosclerosis

Detailed Description:

Changes in the amount of fat and how that fat was distributed were reported after the introduction of antiretroviral therapy (ART) for HIV infected patients. Increases in diabetes, heart disease, and blood levels of glucose and fats have also been reported. However, the cause for these changes is still unclear, in part because clinical measures have not been consistent between different trials. The contribution of age, duration of HIV infection, duration and types of ART, and body weight on metabolic changes need to be defined, and the relationship between metabolic disturbances and body composition changes has also not been established. The purpose of this study is to examine HIV infected adults and use objective measurements of fat to determine metabolic changes in this population, their causes, and possible associations with other observed changes. Data from this study will help guide future treatment plans for HIV infected people to help prevent or lessen the risk for diabetes and cardiovascular disease.

There are 2 parts to this study. Part 1 will examine fat redistribution; there will be 2 groups in Part 1. Group 1 participants will be HIV infected adults recruited from specific HIV clinics. Group 2 participants will be HIV uninfected adults currently enrolled in the Coronary Artery Risk Development in Young Adults (CARDIA) study. Participants will undergo hands-over-head-to-toe wide-slice magnetic resonance imaging (MRI) and dual energy x-ray absorptiometry (DEXA). Imaging measurements will be compared to anthropometric measurements to determine whether anthropometric measurements can accurately quantify fat redistribution. Participants will be asked to self-report fat distribution abnormalities, and this self-reporting will be evaluated for accuracy as compared to the quantitative measures of regional fat distribution. Blood collection will also occur to determine the possible association of body composition changes with the types of ART a participant may have taken or currently be taking.

Part 2 of this study will examine cardiovascular disease and factors for its development; there will be 2 groups in Part 2. Group 1 participants will be HIV infected adults recruited from specific HIV clinics. Group 2 participants will be HIV uninfected adults currently enrolled in the CARDIA study. All participants will be assessed for blood pressure, family history, lifestyle habits, and regional fat volumes by MRI and DEXA. Blood collection will occur to test for glucose and lipids (traditional metabolic risk factors) and C-reactive protein (CRP) and cytokines (novel inflammatory risk factors). Participants will also undergo a carotid intimal medial thickness (IMT) measurement by ultrasound to determine the prevalence of atherosclerosis in this population and associated contributing factors.

For Part 2, there will be a minimum of 2 visits. At both visits, fasting blood collection will occur. A physical exam and self-reporting of lifestyle habits, and completion of questionnaires about smoking, alcohol use, and medical and family history will occur at the first visit.

Study Design


Study Type :	Observational
Enrollment :	1483 participants
Observational Model:	Defined Population
Observational Model:	Natural History
Time Perspective:	Longitudinal
Time Perspective:	Retrospective/Prospective
Official Title:	Fat Redistribution and Metabolic Change in HIV Infection (FRAM)
Study Start Date :	June 2000
Study Completion Date :	July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria for Group 1 in Parts 1 and 2:

HIV infected
Recruited from an HIV clinic participating in this study

Inclusion Criteria for Group 2 in Parts 1 and 2:

HIV uninfected
Participating in the CARDIA study

Exclusion Criteria:

Inability to undergo DEXA and MRI studies

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331448

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Drug Abuse (NIDA)

NIH Office of AIDS Research (OAR)

Investigators


Principal Investigator:	Carl Grunfeld, MD, PhD	Northern California Institute for Research and Education, University of California, San Francisco, Veterans Affairs Medical Center

More Information

Publications of Results:

Bacchetti P, Gripshover B, Grunfeld C, Heymsfield S, McCreath H, Osmond D, Saag M, Scherzer R, Shlipak M, Tien P; Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Fat distribution in men with HIV infection. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):121-31.

Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Fat distribution in women with HIV infection. J Acquir Immune Defic Syndr. 2006 Aug 15;42(5):562-71.

Other Publications:

Safrin S, Grunfeld C. Fat distribution and metabolic changes in patients with HIV infection. AIDS. 1999 Dec 24;13(18):2493-505. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scherzer R, Heymsfield SB, Rimland D, Powderly WG, Tien PC, Bacchetti P, Shlipak MG, Grunfeld C; Study of Fat Redistribution, Metabolic Change in HIV Infection (FRAM). Association of serum albumin and aspartate transaminase with 5-year all-cause mortality in HIV/hepatitis C virus coinfection and HIV monoinfection. AIDS. 2017 Jan 2;31(1):71-79.

Wheeler AL, Scherzer R, Lee D, Delaney JA, Bacchetti P, Shlipak MG, Sidney S, Grunfeld C, Tien PC; Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). HIV/hepatitis C virus coinfection ameliorates the atherogenic lipoprotein abnormalities of HIV infection. AIDS. 2014 Jan 2;28(1):49-58. doi: 10.1097/QAD.0000000000000026.

Kosmiski LA, Scherzer R, Heymsfield SB, Rimland D, Simberkoff MS, Sidney S, Shlipak MG, Bacchetti P, Biggs ML, Grunfeld C; Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Association of increased upper trunk and decreased leg fat with 2-h glucose in control and HIV-infected persons. Diabetes Care. 2011 Nov;34(11):2448-53. doi: 10.2337/dc11-0616. Epub 2011 Sep 16.

Scherzer R, Heymsfield SB, Lee D, Powderly WG, Tien PC, Bacchetti P, Shlipak MG, Grunfeld C; Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Decreased limb muscle and increased central adiposity are associated with 5-year all-cause mortality in HIV infection. AIDS. 2011 Jul 17;25(11):1405-14. doi: 10.1097/QAD.0b013e32834884e6.

Jotwani V, Scherzer R, Choi A, Szczech L, Polak JF, Kronmal RA, Grunfeld C, Shlipak M. Reduced kidney function and preclinical atherosclerosis in HIV-infected individuals: the study of fat redistribution and metabolic change in HIV infection (FRAM). Am J Nephrol. 2011;33(5):453-60. doi: 10.1159/000327606. Epub 2011 Apr 21.

Delaney JA, Scherzer R, Biggs ML, Shliplak MG, Polak JF, Currier JS, Kronmal RA, Wanke C, Bacchetti P, O'leary D, Tien PC, Grunfeld C. Associations of antiretroviral drug use and HIV-specific risk factors with carotid intima-media thickness. AIDS. 2010 Sep 10;24(14):2201-9. doi: 10.1097/QAD.0b013e32833d2132.

Tien PC, Choi AI, Zolopa AR, Benson C, Tracy R, Scherzer R, Bacchetti P, Shlipak M, Grunfeld C. Inflammation and mortality in HIV-infected adults: analysis of the FRAM study cohort. J Acquir Immune Defic Syndr. 2010 Nov;55(3):316-22. doi: 10.1097/QAI.0b013e3181e66216.

Scherzer R, Shen W, Heymsfield SB, Lewis CE, Kotler DP, Punyanitya M, Bacchetti P, Shlipak MG, Grunfeld C; Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Intermuscular adipose tissue and metabolic associations in HIV infection. Obesity (Silver Spring). 2011 Feb;19(2):283-91. doi: 10.1038/oby.2010.115. Epub 2010 Jun 10.

Cockerham L, Scherzer R, Zolopa A, Rimland D, Lewis CE, Bacchetti P, Grunfeld C, Shlipak M, Tien PC. Association of HIV infection, demographic and cardiovascular risk factors with all-cause mortality in the recent HAART era. J Acquir Immune Defic Syndr. 2010 Jan;53(1):102-6. doi: 10.1097/QAI.0b013e3181b79d22.

Grunfeld C, Delaney JA, Wanke C, Currier JS, Scherzer R, Biggs ML, Tien PC, Shlipak MG, Sidney S, Polak JF, O'Leary D, Bacchetti P, Kronmal RA. Preclinical atherosclerosis due to HIV infection: carotid intima-medial thickness measurements from the FRAM study. AIDS. 2009 Sep 10;23(14):1841-9. doi: 10.1097/QAD.0b013e32832d3b85.

Grunfeld C, Rimland D, Gibert CL, Powderly WG, Sidney S, Shlipak MG, Bacchetti P, Scherzer R, Haffner S, Heymsfield SB. Association of upper trunk and visceral adipose tissue volume with insulin resistance in control and HIV-infected subjects in the FRAM study. J Acquir Immune Defic Syndr. 2007 Nov 1;46(3):283-90.


ClinicalTrials.gov Identifier:	NCT00331448 History of Changes
Other Study ID Numbers:	DK-57508 / HL-74814 DK-57508 HL-74814
First Posted:	May 31, 2006 Key Record Dates
Last Update Posted:	August 15, 2006
Last Verified:	May 2006

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):


Treatment Experienced Lipoatrophy Lipohypertrophy Glucose Cholesterol Triglycerides	MRI DXA Carotid IMT LDL HDL

Additional relevant MeSH terms:


Infection HIV Infections Acquired Immunodeficiency Syndrome Atherosclerosis Hyperlipidemias Hyperlipoproteinemias Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Skin Diseases, Metabolic Skin Diseases

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