Metabolic Abnormalities in HIV-infected Persons

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• 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

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