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