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

This study has been completed.
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
HIV Infections
 Dietary Supplement: chromium picolinate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: A Novel Therapy for Glucose Intolerance in HIV Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Primary Outcome Measures:
  • Improvement in insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Enrollment: 39
Study Start Date: November 2005
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chromium Picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
 Dietary Supplement: chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.
Placebo Comparator: Placebo
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00109746

Locations
United States, New York
State University of New York/General Clinical Research Center
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Marie C. Gelato, MD, PhD State University of New York/General Clinical Research Center
  More Information

Publications:

Responsible Party: Marie Gelato, Principal Investigator, Stony Brook University
ClinicalTrials.gov Identifier: NCT00109746     History of Changes
Other Study ID Numbers: R21 AT002499-01A1
Study First Received: May 2, 2005
Last Updated: May 9, 2013
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
HIV
Treatment Experienced
Anti-Retroviral Agents
 Antiretroviral Therapy, Highly Active
Picolinic acid
Dietary Supplements

Additional relevant MeSH terms:
Chromium
Picolinic acid
Chelating Agents
Growth Substances
Iron Chelating Agents
Micronutrients
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents
Trace Elements

ClinicalTrials.gov processed this record on March 03, 2015