ECoM Trial

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Effect of Carnitine Supplementation on Progression of Carotid Plaque in the Metabolic Syndrome.

 

Obesity is one of the main causes of the metabolic syndrome, a condition which is becoming more common in Canada and worldwide. Metabolic syndrome is a name for a group of heart disease risk factors that occur together: obesity, diabetes, high blood pressure, and high cholesterol. These patients have a high risk of developing narrowing and blockages of blood vessels which occur when fat and cholesterol build up in the walls of blood vessels and form plaque. This is called atherosclerosis. Plaque buildup leads to stroke, heart attacks, and death. We do not understand the underlying mechanisms of the metabolic syndrome and we do not have a treatment for it. L-carnitine (L-C), a dietary supplement, has been shown to treat some components of the metabolic syndrome, but its benefit to reduce plaque in the blood vessels has never been studied. Recently there has been some controversy because a new study showed that L-carnitine could make heart disease worse in some patients. Our goal is to study whether supplementation with L-carnitine does in fact prevent or reduce buildup of plaque in blood vessels of patients with the metabolic syndrome. This novel therapy has the potential to decrease the burden of heart disease in obese and diabetic patients with the metabolic syndrome.

 

Research Question: Does L-Carnitine therapy regress atherosclerosis, as measured by total plaque volume (TPV) assessed by 3D carotid ultrasound in patients with MetS?

Study Design: Phase 2, prospective, parallel, double blinded, randomized, placebo-controlled, two-center trial.

Study Population: 160 patients, followed in clinics for CVD prevention, fulfilling diagnosis criteria for MetS will be recruited.

Study Intervention: Following randomization, participants will enter a six month treatment period with either 2 g/day of oral L-C or placebo, both given in divided doses in the morning and evening.

Outcomes: Change in carotid total plaque volume (TPV) at 6 months.

Study status: Funded, Start-up

 

ClinicalTrials.gov

Registered trial: NCT02117661

 

Collaborators:

SPARC

CERU

This trial is funded by the Heart and Stroke Foundation of Canada and the Department of Medicine at Queen's University.