Use of a Nutritional Supplement to Treat Diabetic Symptoms in HIV-Infected Adults - Full Text View

Sponsors and Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00109746

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 I Phase II

MedlinePlus related topics: AIDS Dietary Supplements

Drug Information available for: Dextrose Chromium Chromium picolinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Novel Therapy for Glucose Intolerance in HIV Disease

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
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 to. 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

Contacts

Contact: Marie C. Gelato, MD, PhD

631-444-1175

mgelato@notes.cc.sunysb.edu

Locations

United States, New York
State University of New York/General Clinical Research Center	Recruiting
Stony Brook, New York, United States, 11794
Contact: Marie C. Gelato, MD, PhD 631-444-1175 mgelato@notes.cc.sunysb.edu
Contact: Diane Ruenes 631-444-6900 druenes@notes.cc.sunysb.edu
Principal Investigator: Marie C. Gelato, MD, PhD
General Clinical Research Center at University Hospital	Recruiting
Stony Brook, New York, United States, 11794-8154
Contact: Jennifer Intravaia 631-444-3740 jennifer.intravaia@stonybrook.edu
Contact: Marie Gelato, MD,PhD 631 444 1175 mgelato@notes.cc.sunysb.edu
Principal Investigator: Marie Gelato, MD,PhD

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:

El-Sadr WM, Mullin CM, Carr A, Gibert C, Rappoport C, Visnegarwala F, Grunfeld C, Raghavan SS. Effects of HIV disease on lipid, glucose and insulin levels: results from a large antiretroviral-naive cohort. HIV Med. 2005 Mar;6(2):114-21.

Howard AA, Floris-Moore M, Arnsten JH, Santoro N, Fleischer N, Lo Y, Schoenbaum EE. Disorders of glucose metabolism among HIV-infected women. Clin Infect Dis. 2005 May 15;40(10):1492-9. Epub 2005 Apr 11.

Taiwo BO. Insulin resistance, HIV infection, and anti-HIV therapies. AIDS Read. 2005 Apr;15(4):171-6, 179-80. Review.

Responsible Party:	Stony Brook University ( Marie C. Gelato, MD, PhD )
Study ID Numbers:	R21 AT002499-01A1
Study First Received:	May 2, 2005
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00109746
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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Metabolic Diseases
Chromium
Picolinic acid
Acquired Immunodeficiency Syndrome
Glucose Intolerance
Immunologic Deficiency Syndromes
Virus Diseases

Hyperinsulinism
HIV Infections
Sexually Transmitted Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Iron
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents

Trace Elements
Infection
Pharmacologic Actions
Lentivirus Infections
Micronutrients
Chelating Agents

ClinicalTrials.gov processed this record on January 15, 2009