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HIV InfectionsNCT00331448

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

An observational study of HIV Infections and Lipodystrophy, run by National Institute of Allergy and Infectious Diseases (NIAID).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections, Lipodystrophy, Diabetes
How many people
1,483 participants
Where
No sites listed yet
Study dates
Jun 2000to Jul 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • HIV infected
  • Recruited from an HIV clinic participating in this study
  • HIV uninfected
  • Participating in the CARDIA study

Who cannot join

  • Inability to undergo DEXA and MRI studies

About this study

Official title: Fat Redistribution and Metabolic Change in HIV Infection (FRAM)

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.

Read the 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.

Keywords
Treatment Experienced, Lipoatrophy, Lipohypertrophy, Glucose, Cholesterol, Triglycerides, MRI, DXA, Carotid IMT, LDL, HDL
Medical subject headings
HIV Infections, Lipodystrophy, Diabetes Mellitus, Hyperlipidemias, Atherosclerosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2006 (estimated)
  2. Study startJun 2000
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
1,483 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00331448
Sponsor's protocol ID
DK-57508 / HL-74814
Other IDs
DK-57508, HL-74814
Status last verified
May 2006
First submitted
30 May 2006
Last updated
15 Aug 2006
Results posted
No

Publications

  • 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.

    PubMed 10630518

  • 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.

    PubMed 16186728

  • 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.

    PubMed 16837863

  • 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.

    PubMed 27677166

  • 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.

    PubMed 24136113

  • 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.

    PubMed 21926283

  • 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.

    PubMed 21572308

  • 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.

    PubMed 21508633

  • 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.

    PubMed 20671544

  • 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.

    PubMed 20581689

  • 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.

    PubMed 20539305

  • 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.

    PubMed 19738484

  • 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.

    PubMed 19455012

  • 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.

    PubMed 18167644

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Lipodystrophy, run by National Institute of Allergy and Infectious Diseases (NIAID).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00331448, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2006.

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