Metabolic Abnormalities in HIV-infected Persons

HIV Infection Clinical Trial

Official title:

Metabolic Abnormalities in HIV-infected Persons

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01612858
• Other study ID #: CLAMP-K23
• Secondary ID: 1K23DK079789-01A
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: April 28, 2015
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• Lipodystrophy

Intervention

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.
• Pioglitazone
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		3 months	No
Secondary	Lipid content		3 months	No