This trial is active, not recruiting.

Conditions lipodystrophy, hiv infection
Treatments metformin, pioglitazone
Phase phase 4
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
metformin Fortamet
Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
pioglitazone Actos
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.

Primary Outcomes

Insulin sensitivity
time frame: 3 months

Secondary Outcomes

Lipid content
time frame: 3 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Tufts Medical Center.