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

• ClinicalTrials.gov Identifier: NCT00109746
• Recruitment Status: Completed
• First Posted: May 3, 2005
• Last Update Posted: March 23, 2016
• Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborator: Office of Dietary Supplements (ODS)
• Information provided by (Responsible Party): Marie Gelato, Stony Brook University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Insulin Resistance; HIV Infections	Dietary Supplement: chromium picolinate	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: A Novel Therapy for Glucose Intolerance in HIV Disease
• Study Start Date: November 2005
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Improvement in insulin sensitivity [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: R21 AT002499-01A1
• First Posted: May 3, 2005
• Last Update Posted: March 23, 2016
• Last Verified: May 2013

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:

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Chromium; Picolinic acid; Trace Elements; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Iron Chelating Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action