Trial record 10 of 37 for:    " May 30, 2012":" June 29, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Metabolic Abnormalities in HIV-infected Persons (CLAMP)

This study is currently recruiting participants.
Verified December 2013 by Tufts Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01612858
First received: June 4, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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
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:
  • 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.

  Eligibility

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

Inclusion Criteria:

  • Age 18-60 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612858

Contacts
Contact: Rakhi Kohli, MD 617-636-4709 rkohli@tuftsmedicalcenter.org
Contact: Hareg Woldetensay, BA 617-636-8593 hwoldetensay@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Rakhi Kohli, MD, MS         
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Rakhi Kohli, MD, MS Tufts Medical Center
  More Information

No publications provided

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
Last Updated: December 6, 2013
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
Acquired Immunodeficiency Syndrome
Congenital Abnormalities
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014