Metabolic Abnormalities in HIV-infected Persons

Phase 4

Completed

• Conditions: HIV Infection; Lipodystrophy
• Interventions: Drug: Metformin; Drug: Pioglitazone

• Registration Number: NCT01612858
• Lead Sponsor: Tufts Medical Center

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-05
• Results First Submitted: 2016-05-12
• Results First Submitted QC: 2016-05-12
• Last Update Submitted: 2016-05-12
• Results First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-
Pioglitazone	Pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent	3 months	Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone

Secondary Outcome Measures

Name	Time	Method
Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent	12 weeks	Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States