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Observational Study of Changes in Fat Distribution and Blood Metabolites in HIV Infected Adults
This study is ongoing, but not recruiting participants.
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)
Office of AIDS Research
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00331448
  Purpose

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
HIV Infections
Lipodystrophy
Diabetes
Hyperlipidemia
Atherosclerosis

MedlinePlus related topics: AIDS Diabetes
Drug Information available for: Dextrose Cholest-5-en-3-ol (3beta)-
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: Fat Redistribution and Metabolic Change in HIV Infection (FRAM)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331448

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

Click here for more information on hyperglycemia  This link exits the ClinicalTrials.gov site
Click here for more information on hyperlipidemia  This link exits the ClinicalTrials.gov site
Click here for more information on lipodystrophy  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Lipoatrophy
Lipohypertrophy
Glucose
Cholesterol
Triglycerides
MRI
DXA
Carotid IMT
LDL
HDL

Study placed in the following topic categories:
Atherosclerosis
Arterial Occlusive Diseases
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Hyperlipidemias
Skin Diseases
Acquired Immunodeficiency Syndrome
Vascular Diseases
Diabetes Mellitus
Arteriosclerosis
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Metabolic disorder
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Skin Diseases, Metabolic
Lentivirus Infections
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 15, 2009