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To Determine If Chromium Nicotinate Supplementation at 400ug/Day for 16 Weeks Will Improve Insulin Resistance in HIV Patients with Metabolic Abnormalities - Article


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Cholesterol

 



Clinical Trial: To Determine If Chromium Nicotinate Supplementation at 400ug/Day for 16 Weeks Will Improve Insulin Resistance in HIV Patients with Metabolic Abnormalities

This study is currently recruiting patients.
Verified by University Health Network, Toronto September 2005

Sponsors and Collaborators: University Health Network, Toronto
Canadian Foundation for AIDS research
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152893

Purpose

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

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Randomized, Open Label, Placebo Control, Crossover Assignment

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

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

Study start: August 2002

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

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.

Location and Contact Information

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
Ellie Aghdassi, PhD, RD  416-340-4800  Ext. 4113    ellie.aghdassi@uhn.on.ca 
Johane Allard, MD, FRCPC,  Principal Investigator

Study chairs or principal investigators

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

More Information

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

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