Metabolic Abnormalities in HIV-infected Persons

This study is ongoing, but not recruiting participants.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center Identifier:
First received: June 4, 2012
Last updated: April 28, 2015
Last verified: April 2015
This 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.

Condition Intervention Phase
HIV Infection
Drug: Metformin
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Abnormalities in HIV-infected Persons

Resource links provided by NLM:

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid content [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Fortamet
  • Glucophage
  • Glumetza
  • Riomet
Experimental: Pioglitazone Drug: Pioglitazone
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Other Name: Actos

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.

Insulin resistance is a pre-disease condition that often leads to diabetes after 10 to 20 years. Insulin is a hormone made by the body that tells the body to store glucose in muscle and fat. People with insulin resistance often need more insulin to store the same amount of glucose. Both insulin resistance and changes in fat distribution in HIV-infected persons are areas of active research because they are both associated with an increased risk of heart disease.

This study examines the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study will recruit both HIV-infected and uninfected persons. The investigators will compare findings between HIV-infected persons with central fat deposition and HIV-infected persons with peripheral fat atrophy, as well as between HIV-infected and uninfected persons.

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-70 years
  • Fasting insulin ≥15 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01612858

United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Rakhi Kohli, MD, MS Tufts Medical Center
  More Information

Responsible Party: Tufts Medical Center Identifier: NCT01612858     History of Changes
Other Study ID Numbers: CLAMP-K23  1K23DK079789-01A2 
Study First Received: June 4, 2012
Last Updated: April 28, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Tufts Medical Center:
Insulin resistance
HIV infection

Additional relevant MeSH terms:
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Virus Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 30, 2016