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

This study is currently recruiting participants.

Verified by University Health Network, Toronto, February 2007

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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: chromium nicotinate	Phase II

MedlinePlus related topics: AIDS Cholesterol

Drug Information available for: Insulin Dextrose Cholest-5-en-3-ol (3beta)- Niacin Niacin hydrochloride Chromium Lipids Chromium nicotinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

insulin resistance calculated using fasting glucose and fasting insulin levels in blood

Secondary Outcome Measures:

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

Estimated Enrollment:	68
Study Start Date:	August 2002

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152893

Contacts

Contact: Ellie Aghdassi, PhD, RD

416-340-4800 ext 4413

ellie.aghdassi@uhn.on.ca

Locations

Canada, Ontario
University Health Network - Toronto General Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Ellie Aghdassi, PhD, RD 416-340-4800 ext 4413 ellie.aghdassi@uhn.on.ca
Principal Investigator: Johane Allard, MD, FRCPC

Sponsors and Collaborators

University Health Network, Toronto

Canadian Foundation for AIDS Research (CANFAR)

Investigators

Principal Investigator:

Johane Allard, MD, FRCPC

University Health Network - Toronto General Hospital

More Information

Study ID Numbers:	03-0703-A, 015 027
Study First Received:	September 8, 2005
Last Updated:	March 6, 2007
ClinicalTrials.gov Identifier:	NCT00152893
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by University Health Network, Toronto:

HIV
blood sugar > 6.1 mmol/l
triglycerides > 2 mmol/l
total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Chromium
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Insulin
Virus Diseases
Nicotinic Acids

HIV Infections
Sexually Transmitted Diseases
Insulin Resistance
Congenital Abnormalities
Retroviridae Infections
Niacin

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
RNA Virus Infections
Vasodilator Agents
Vitamin B Complex
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antilipemic Agents
Growth Substances

Physiological Effects of Drugs
Trace Elements
Cardiovascular Agents
Infection
Pharmacologic Actions
Vitamins
Therapeutic Uses
Lentivirus Infections
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009