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

HIV Infections Clinical Trial

— NT  

Official title:

A Novel Therapy for Glucose Intolerance in HIV Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109746
• Other study ID #: R21 AT002499-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 2, 2005
• Last updated: March 22, 2016
• Start date: November 2005
• Est. completion date: June 2010

Study information

• Verified date: May 2013
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections
• Insulin Resistance

Intervention

Dietary Supplement:
• chromium picolinate
HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Locations

Country	Name	City	State
United States	State University of New York/General Clinical Research Center	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in insulin sensitivity		8 weeks	Yes