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

June 4, 2012
May 12, 2016
June 2011
November 2014   (final data collection date for primary outcome measure)
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
Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01612858 on ClinicalTrials.gov Archive Site
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
Lipid content [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Metabolic Abnormalities in HIV-infected Persons
Metabolic Abnormalities in HIV-infected Persons
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lipodystrophy
  • HIV Infection
  • 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
  • Drug: Pioglitazone
    Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
    Other Name: Actos
  • Experimental: Metformin
    Intervention: Drug: Metformin
  • Experimental: Pioglitazone
    Intervention: Drug: Pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01612858
CLAMP-K23, 1K23DK079789-01A2
Yes
Not Provided
Not Provided
Tufts Medical Center
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Rakhi Kohli, MD, MS Tufts Medical Center
Tufts Medical Center
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP