Metabolic Abnormalities in HIV-infected Persons
This trial is active, not recruiting.
|Conditions||lipodystrophy, hiv infection|
|Sponsor||Tufts Medical Center|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||June 2011|
|End date||April 2015|
|Trial size||70 participants|
|Trial identifier||NCT01612858, 1K23DK079789-01A2, CLAMP-K23|
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 measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 3 months
time frame: 3 months
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - Age 18-70 years - Fasting insulin ≥15 μU/mL and/or serum glucose between 140-200 mg/dL after 75 g 2hr oral glucose tolerance test - 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
|Official title||Metabolic Abnormalities in HIV-infected Persons|
|Principal investigator||Rakhi Kohli, MD, MS|
|Description||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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