Metabolic Abnormalities in HIV-infected Persons

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Brief Title

Metabolic Abnormalities in HIV-infected Persons

Official Title

Metabolic Abnormalities in HIV-infected Persons

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent

Secondary Outcome

 Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent

Condition

Lipodystrophy

Intervention

Metformin

Study Arms / Comparison Groups

 Metformin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

June 2011

Completion Date

November 2014

Primary Completion Date

November 2014

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Rakhi Kohli, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01612858

Organization ID

CLAMP-K23

Secondary IDs

1K23DK079789-01A2

Responsible Party

Sponsor

Study Sponsor

Tufts Medical Center

Collaborators

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

Study Sponsor

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


Verification Date

May 2016