Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults (NT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marie Gelato, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00109746
First received: May 2, 2005
Last updated: May 9, 2013
Last verified: May 2013

May 2, 2005
May 9, 2013
November 2005
May 2009   (final data collection date for primary outcome measure)
Improvement in insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Improvement in insulin sensitivity
Complete list of historical versions of study NCT00109746 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults
A Novel Therapy for Glucose Intolerance in HIV Disease

The purpose of this study is to determine the effectiveness of the nutritional supplement chromium picolinate in improving insulin resistance, a symptom of diabetes, in HIV-infected patients. The ultimate goal is to find a simple therapy that can prevent the development of diabetes in individuals with HIV.

Insulin resistance occurs when blood glucose levels get too high for the body to respond. Certain anti-HIV drugs are associated with increased insulin resistance and may lead to abnormal fat distribution, hypertension, and type 2 diabetes mellitus. The dietary supplement chromium picolinate has been shown to safely improve insulin sensitivity in patients with type 2 diabetes mellitus with no serious side effects. However, the effects of the supplement have not been thoroughly examined in HIV-infected individuals. This study will determine the effectiveness of chromium picolinate in improving insulin resistance in HIV-infected individuals.

This study will last 2 months. Participants will be randomly assigned to receive either chromium picolinate or placebo once a day for 2 months. Participants will have four overnight visits at the research center and two additional daytime visits for safety monitoring. During the overnight visits, participants will undergo a euglycemic hyperinsulinemic clamp, in which a continuous infusion of insulin is given through a vein and glucose levels are monitored through blood samples taken every 5 to 10 minutes. Fat tissue biopsies will also be conducted at the overnight study visits. During the safety monitoring visits, blood collection will occur for kidney and liver function tests, CD4 count, and viral load assessment.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
  • Insulin Resistance
  • HIV Infections
Dietary Supplement: chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
  • Active Comparator: Chromium Picolinate
    HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
    Intervention: Dietary Supplement: chromium picolinate
  • Placebo Comparator: Placebo
    HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
June 2010
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected
  • Currently taking an anti-HIV drug regimen
  • Insulin Resistant:fasting glucose between 5.56 and 7mmol/L and/or two hour post-glucose load between 7.78 and 11.11mmol/L

Exclusion Criteria:

  • Cancer
  • Acute illness that would interfere with the study
  • Hypogonadism
  • Hypothyroidism
  • Untreated hypertension
  • CD4 count less than 300 cells/mm3
  • Viral load greater than 35,000 copies/ml
  • Untreated hepatitis C virus infection
  • Pregnancy
  • Diabetes
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109746
R21 AT002499-01A1
Yes
Marie Gelato, Stony Brook University
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Principal Investigator: Marie C. Gelato, MD, PhD State University of New York/General Clinical Research Center
National Center for Complementary and Alternative Medicine (NCCAM)
May 2013

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