View Clinical Trial (Medical Research Study)
Metabolic Abnormalities in HIV-infected Persons
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02111 |
| Conditions: |
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Lipodystrophy - HIV Infection |
| Purpose: |
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This purpose of this study is to examine the relationship between insulin resistance and
changes in body fat distribution in HIV-infected persons. This study seeks to measure
insulin sensitivity in HIV-infected persons with a gold-standard test, and seeks to
determine the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin
sensitivity and fat in this population.
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| Study Summary: |
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Although HIV antiretroviral medications have helped patients live longer, they have also
been associated with side effects including insulin resistance and changes in body fat
distribution. Changes in body fat distribution associated with HIV antiretroviral
medications may result in increased fat in the abdomen, neck, and upper back, which is often
called central fat deposition. HIV antiretroviral medications may also result in loss of
fat in legs, arms, and face, which is often called peripheral fat atrophy.
Insulin resistance is a pre-disease condition that often leads to diabetes after 10 to 20
years. Insulin is a hormone made by the body that tells the body to store glucose in muscle
and fat. People with insulin resistance often need more insulin to store the same amount of
glucose. Both insulin resistance and changes in fat distribution in HIV-infected persons
are areas of active research because they are both associated with an increased risk of
heart disease.
This study examines the relationship between insulin resistance and changes in body fat
distribution in HIV-infected persons. This study will recruit both HIV-infected and
uninfected persons. The investigators will compare findings between HIV-infected persons
with central fat deposition and HIV-infected persons with peripheral fat atrophy, as well as
between HIV-infected and uninfected persons.
This study involves taking a drug that has been approved by the U.S. Food and Drug
Administration (FDA) for use in humans for a period of 3 months.
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| Criteria: |
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Inclusion Criteria:
- Age 18-60 years
- Fasting insulin ≥15 μU/mL and/or serum glucose between 140-200 mg/dL after 75 g 2hr
OGTT
- Central fat deposition or Peripheral fat atrophy
- Fasting glucose ≤126 mg/dL
- BMI ≥18 and ≤35 kg/m2
- CD4 cell count ≥100 cells/mm3
- Stable antiretroviral regimen ≥12 weeks and HIV RNA <1000 copies
Exclusion Criteria:
- Diabetes mellitus
- Cardiac pacemaker or metal implant
- Liver enzymes >2.5x upper normal limit
- Alkaline phosphatase or prothrombin time >2x upper normal limit
- Serum creatinine >1.4 mg/dL
- History of congestive heart failure
- Hemoglobin <8 g/dL
- Alcohol abuse
- Pregnancy
- History of lactic acidosis
- Use of steroids
- Acute infection within last one month
- History of bladder cancer
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| NCT ID: |
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NCT01612858 |
| Primary Contact: |
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Principal Investigator
Rakhi Kohli, MD, MS
Tufts Medical Center
Aretha Ren, BA
Phone: 617-636-5439
Email: aren@tuftsmedicalcenter.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02111
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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