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

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Brief Title

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

Official Title

Fat Redistribution and Metabolic Change in HIV Infection (FRAM)

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.
    

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 Type

Observational




Condition

HIV Infections



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1483

Start Date

June 2000

Completion Date

July 2007


Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Carl Grunfeld, MD, PhD, , 



Administrative Informations


NCT ID

NCT00331448

Organization ID

DK-57508 / HL-74814

Secondary IDs

DK-57508


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

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

Study Sponsor

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


Verification Date

May 2006