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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
NIH Office of AIDS Research (OAR)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
First received: May 30, 2006
Last updated: August 10, 2006
Last verified: May 2006

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.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Fat Redistribution and Metabolic Change in HIV Infection (FRAM)

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 1483
Study Start Date: June 2000
Estimated Study Completion Date: July 2007
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331448

Sponsors and Collaborators
NIH Office of AIDS Research (OAR)
Principal Investigator: Carl Grunfeld, MD, PhD Northern California Institute for Research and Education, University of California, San Francisco, Veterans Affairs Medical Center
  More Information

Additional Information:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00331448     History of Changes
Other Study ID Numbers: DK-57508 / HL-74814, DK-57508, HL-74814
Study First Received: May 30, 2006
Last Updated: August 10, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Carotid IMT

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Arterial Occlusive Diseases
Cardiovascular Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Vascular Diseases
Virus Diseases

ClinicalTrials.gov processed this record on September 03, 2015