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

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Health Services Research
Official Title:	A Novel Therapy for Glucose Intolerance in HIV Disease

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements HIV/AIDS

Drug Information available for: Chromium Chromium picolinate Zinc picolinate

U.S. FDA Resources

Further study details as provided by Marie Gelato, Stony Brook University:

Primary Outcome Measures:

Improvement in insulin sensitivity [ Time Frame: 8 weeks ]


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.
No Intervention: 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 (Adult, Senior)
Sexes Eligible for Study:	All
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:

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:	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:	March 22, 2016

Keywords provided by Marie Gelato, Stony Brook University:


HIV Treatment Experienced Anti-Retroviral Agents	Antiretroviral Therapy, Highly Active Picolinic acid Dietary Supplements

Additional relevant MeSH terms:


HIV Infections Insulin Resistance Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders	Metabolic Diseases Chromium Picolinic acid Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017

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