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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Therapy for Glucose Intolerance in HIV Disease

Conditions
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Insulin Resistance, HIV Infections

Intervention / Treatment
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* Dietary Supplement: chromium picolinate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chromium Picolinate<br>HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months. | Dietary Supplement: chromium picolinate<br>* HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months.<br>|
| No Intervention: Placebo<br>HIV+ and control may receive 500µg of chromium picolinate or placebo twice daily for two months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in insulin sensitivity |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Treatment Experienced, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, Picolinic acid, Dietary Supplements