Observational Study of Changes in Fat Distribution and Blood Metabolites in HIV Infected Adults
NCT ID: NCT00331448
Last Updated: 2006-08-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
1483 participants
Study Classification
OBSERVATIONAL
Study Start Date
2000-06-30
Study Completion Date
2007-07-31
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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HIV Infections
Lipodystrophy
Diabetes
Hyperlipidemia
Atherosclerosis
Keywords
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Treatment Experienced
Lipoatrophy
Lipohypertrophy
Glucose
Cholesterol
Triglycerides
MRI
DXA
Carotid IMT
LDL
HDL
Study Design
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Observational Model Type
DEFINED_POPULATION
Study Time Perspective
OTHER
Eligibility Criteria
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Inclusion Criteria
* HIV infected
* Recruited from an HIV clinic participating in this study
* HIV uninfected
* Participating in the CARDIA study
* Recruited from an HIV clinic participating in this study
* HIV uninfected
* Participating in the CARDIA study
Exclusion Criteria
* Inability to undergo DEXA and MRI studies
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
National Institute on Drug Abuse (NIDA)
NIH
Sponsor Role
collaborator
NIH Office of AIDS Research (OAR)
NIH
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
lead
Principal Investigators
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Carl Grunfeld, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Northern California Institute for Research and Education, University of California, San Francisco, Veterans Affairs Medical Center
References
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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. doi: 10.1097/qai.0b013e31814b94e2.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Safrin S, Grunfeld C. Fat distribution and metabolic changes in patients with HIV infection. AIDS. 1999 Dec 24;13(18):2493-505. doi: 10.1097/00002030-199912240-00002. No abstract available.
Reference Type
BACKGROUND
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. doi: 10.1097/01.qai.0000182230.47819.aa.
Reference Type
RESULT
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. doi: 10.1097/01.qai.0000229996.75116.da.
Reference Type
RESULT
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. doi: 10.1097/QAD.0000000000001278.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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DK-57508
Identifier Type: -
Identifier Source: secondary_id
HL-74814
Identifier Type: -
Identifier Source: secondary_id
DK-57508 / HL-74814
Identifier Type: -
Identifier Source: org_study_id