Metabolic Abnormalities in HIV-infected Persons

Tufts University

Status and phase

Completed

Phase 4

Conditions

HIV Infection

Lipodystrophy

Treatments

Drug: Pioglitazone

Drug: Metformin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01612858

1K23DK079789-01A2 (U.S. NIH Grant/Contract)

CLAMP-K23

Details and patient eligibility

About

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.

Full 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.

This study will obtain preliminary data on the effect of 12 weeks of metformin on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and central fat deposition. Similarly, this study will obtain preliminary data on the effect of 12 weeks of pioglitazone on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and peripheral fat atrophy.

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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