Metabolic Abnormalities in HIV-infected Persons

May 12, 2016 updated by: Tufts Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pioglitazone
Drug: Pioglitazone
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Other Names:
  • Actos
EXPERIMENTAL: Metformin
Drug: Metformin
Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
Other Names:
  • Glucophage
  • Glumetza
  • Fortamet
  • Riomet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Rakhi Kohli, MD, MS, Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (ESTIMATE)

June 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAMP-K23
  • 1K23DK079789-01A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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