Clinical trial NCT00152893: To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
Official title: The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
blood sugar > 6.1 mmol/l
triglycerides > 2 mmol/l
total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for AIDS Research (CANFAR)
First posted: 2005-09-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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. 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.

Primary outcomes:
measure: insulin resistance calculated using fasting glucose and fasting insulin levels in blood
timeFrame: BL & 16 weeks
Secondary outcomes:
measure: hemoglobin A1c (HbA1c)
timeFrame: BL & 16 weeks
measure: blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL])
timeFrame: BL & 16 weeks
measure: body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement
timeFrame: BL & 16 weeks
measure: oxidative stress
timeFrame: BL & 16 weeks
measure: plasma chromium
timeFrame: BL & 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network - Toronto General Hospital
name: Johane Allard, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aghdassi E, Arendt B, Salit IE, Allard JP. Estimation of body fat mass using dual-energy x-ray absorptiometry, bioelectric impedance analysis, and anthropometry in HIV-positive male subjects receiving highly active antiretroviral therapy. JPEN J Parenter Enteral Nutr. 2007 Mar-Apr;31(2):135-41. doi: 10.1177/0148607107031002135.
citation: Aghdassi E, Arendt BM, Salit IE, Mohammed SS, Jalali P, Bondar H, Allard JP. In patients with HIV-infection, chromium supplementation improves insulin resistance and other metabolic abnormalities: a randomized, double-blind, placebo controlled trial. Curr HIV Res. 2010 Mar;8(2):113-20. doi: 10.2174/157016210790442687.
citation: Arendt BM, Aghdassi E, Mohammed SS, Fung LY, Jalali P, Salit IE, Allard JP. Dietary intake and physical activity in a Canadian population sample of male patients with HIV infection and metabolic abnormalities. Curr HIV Res. 2008 Jan;6(1):82-90. doi: 10.2174/157016208783571973.