Effect of Carnitine Supplementation on Progression of Carotid Plaque in 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
Significance: In 2009, cardiovascular disease (CVD) accounted for 27% of all deaths in Canada and it is now the leading cause of death worldwide. The development of novel therapies to reduce CVD is of paramount importance. L-carnitine (L-C) is a potential therapy that may benefit patients with CVD, but its effect on human atherosclerosis, the most important contributor to CVD events, has never been studied. Currently there is controversy about whether L-C may promote atherosclerosis. We urgently need a randomized clinical trial (RCT) to resolve this question.
This trial is registered at ClinicalTrials.gov (NCT02117661).
Dr. Amer Johri, Principal Investigator
Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
Marie-France Hetu, PhD, Project Leader