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

Phase 1

Completed

• Conditions: Insulin Resistance; HIV Infections
• Interventions: Dietary Supplement: chromium picolinate

• Registration Number: NCT00109746
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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.

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 Timeline

• Study First Submitted: 2005-05-02
• Study First Submitted QC: 2005-05-02
• Study First Posted: 2005-05-03
• Study Start: 2005-11
• Primary Completion: 2009-05
• Study Completion: 2010-06
• Status Verified: 2013-05
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chromium Picolinate	chromium picolinate	HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.

Primary Outcome Measures

Name	Time	Method
Improvement in insulin sensitivity	8 weeks

Trial Locations

Locations (1)

State University of New York/General Clinical Research Center; 🇺🇸 Stony Brook, New York, United States