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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:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00109746
First received: May 2, 2005
Last updated: August 23, 2010
Last verified: August 2010
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 piccolinate
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: Treatment
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 Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Improvement in insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2005
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Double blinded study to assess chromium picolinate's effect on insulin sensitivity in HIV+ subjects
 Dietary Supplement: Chromium piccolinate
2 tablets per day
Dietary Supplement: Chromium Picolinate
2 tablets per day for 8 weeks
Dietary Supplement: Chromium Picolinate
2 tablets per day

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

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
  Contacts and Locations
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
General Clinical Research Center at University Hospital
Stony Brook, New York, United States, 11794-8154
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
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 C. Gelato, MD, PhD, 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: August 23, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Insulin Resistance
Glucose Intolerance
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
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Hyperglycemia
Chromium
Picolinic acid
Anti-Retroviral Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 07, 2013