Metabolic Abnormalities in HIV-infected Persons

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01612858
First received: June 4, 2012
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Lipodystrophy
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:
  • Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (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.

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612858

Locations
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)
Investigators
Principal Investigator: Rakhi Kohli, MD, MS Tufts Medical Center
  More Information

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01612858     History of Changes
Other Study ID Numbers: CLAMP-K23  1K23DK079789-01A2 
Study First Received: June 4, 2012
Results First Received: May 12, 2016
Last Updated: May 12, 2016
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:
Lipodystrophy
Insulin resistance
HIV infection

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016