Clinical trial NCT01612858: Metabolic Abnormalities in HIV-infected Persons
Official title: Metabolic Abnormalities in HIV-infected Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lipodystrophy
HIV Infection
Keywords: Lipodystrophy
Insulin resistance
HIV infection
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent
timeFrame: 3 months
Secondary outcomes:
measure: Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Rakhi Kohli, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: