Metabolic Abnormalities in HIV-infected Persons

Completed · Phase 4

Conditions studied: Lipodystrophy, HIV Infection

In brief

The 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.

Key facts

Study ID

NCT01612858

Run by

Tufts Medical Center

People needed

20

Starts

2011-06-01

Expected to finish

2014-11-01

Last updated by the study team

2016-06-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-70 years
• Fasting insulin >12 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

You may not qualify if…

• 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

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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