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

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ClinicalTrials.gov Identifier: NCT00331448
Recruitment Status : Unknown
Verified May 2006 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2006
Last Update Posted : August 15, 2006
Information provided by:

Study Description
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.

Condition or disease
HIV Infections Lipodystrophy Diabetes Hyperlipidemia Atherosclerosis

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 Design

Study Type : Observational
Estimated Enrollment : 1483 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Fat Redistribution and Metabolic Change in HIV Infection (FRAM)
Study Start Date : June 2000
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331448

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Drug Abuse (NIDA)
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

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
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: May 2006

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

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