To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities

Study Overview
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Brief Summary
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In HIV patients, fasting insulin levels decrease with chromium supplementation. This study is to determine if chromium nicotinate supplementation at 400ug/day for 16 weeks will improve insulin resistance in HIV patients with metabolic abnormalities.

Detailed Description
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This study is a randomized, double-blind, placebo-controlled, crossover study where patients will be supplemented for 16 weeks with either chromium nicotinate 400 ug/day or placebo and then crossover to the opposite treatment for another 16 weeks. Each soft gel capsule of chromium contains 200ug of chromium and patients will take 1 capsule twice a day or its placebo. Placebo contains di-calcium phosphate in a soft gel capsule and its appearance is similar to the chromium capsules.

Official Title
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The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: chromium nicotinate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV documented patients will be considered for the study if they have at least one abnormality with respect to fasting blood glucose, TG, total or HDL cholesterol. Normal fasting glucose is defined as < 6.1 mmol/L. Hypertriglyceridemia is defined as concentrations above 2.0 mmol/L on the basis of reports of increased risk of cardiac disease. Hypercholesterolemia is defined as concentrations above 5.5 mmol/L and a low HDL-cholesterol concentration as less than 0.9 mmol/L. Patients will need to be on a stable drug regimen for at least 8 weeks and not taking any chromium supplement or chromium-containing multivitamins 4 weeks prior to and during the study period. Patients can stay on their hypoglycemic or lipid-lowering medications and the required dosage will be monitored. Exclusion Criteria: Patients will be excluded if there is concomitant acute infection or malignancy.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chromium<br>400 μg (200 μg pills, twice per day) of Cr-nicotinate | Drug: chromium nicotinate<br> <br> |
| Placebo Comparator: Placebo<br>Identical looking placebo (di-calcium phosphate) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance calculated using fasting glucose and fasting insulin levels in blood | HOMA-IR | BL & 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin A1c (HbA1c) |  | BL & 16 weeks | 
| blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL]) |  | BL & 16 weeks | 
| body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement |  | BL & 16 weeks | 
| oxidative stress |  | BL & 16 weeks | 
| plasma chromium |  | BL & 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, blood sugar > 6.1 mmol/l, triglycerides > 2 mmol/l, total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l