In HIV patines, fasting insulin level decreases with chromium supplmentation. This study is to determine if chromium nicotinate supplementation at 400 ug/day for 16 weeks will imporve insulin resistance in HIV patients with metabolic abnormalities

Condition	Intervention	Phase
HIV blood sugar > 6.1 mmol/l triglycerides > 2 mmol/l total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l	Drug: chromium nicotinate	Phase II

Further Study Details: 

Primary Outcomes: insulin resistance calculated usig fasting glucose and fasting insulin level in blood
Secondary Outcomes: HbA1c; blood lipid profile (TG, chol or HDL); body composition by DEXA scan, BIOELECTRIC Impedance analysis and skin fold measurement; oxidative stress; plasma chromium
Expected Total Enrollment:  68

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 (158). Hypertriglyceridemia is defined as concentrations above 2.0 mmol/L on the basis of reports of increased risk of cardiac disease (159). Hypercholesterolemia is defined as concentrations above 5.5 mmol/L and a low HDL-cholesterol concentration as less than 0.9 mmol/L (160, 161). 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 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00152893

Ellie Aghdassi, PhD, RD      416-340-4800  Ext. 4113    ellie.aghdassi@uhn.on.ca

Canada, Ontario
      University Health Network - Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada; Recruiting

Study chairs or principal investigators

Johane Allard, MD, FRCPC,  Principal Investigator,  University Health Network - Toronto General Hospital   

Study ID Numbers:  03-0703-A; 015 027
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152893
Health Authority: Canada: Ethics Review Committee; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13