HIV Infections
Conditions
Keywords
HIV, blood sugar > 6.1 mmol/l, triglycerides > 2 mmol/l, total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l
Brief summary
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
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.
Interventions
DRUGPlacebo
Sponsors
Canadian Foundation for AIDS Research (CANFAR)
Johane Allard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insulin resistance calculated using fasting glucose and fasting insulin levels in blood | BL & 16 weeks | HOMA-IR |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed