NCT02117661

Carnitine for the Treatment of Atherosclerosis.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Dr. Amer Johri · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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, 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.

Detailed description

Primary Question: Does L-carnitine (L-C) therapy slows down and/or regress atherosclerosis, as measured by total plaque volume (TPV) assessed by 3-dimensional (3D) carotid ultrasound in patients with metabolic syndrome? We hypothesize that L-C will regress atherosclerotic plaque formation. To assess our primary outcome of L-C induced atherosclerosis regression, we anticipate a significant percent (%) difference in carotid total plaque volume (TPV) over six months of L-C treatment, compared to placebo. For our secondary outcome, we expect to show that L-C therapy compared to placebo, induces a reduction in the proportion of small-sized LDL and an increase in large LDL particles. As small dense LDL particles are more atherogenic than large buoyant ones, this would suggest a mechanism contributing to the atherosclerosis reduction induced by L-C therapy.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-carnitine capsules	Oral
DIETARY_SUPPLEMENT	Cellulose capsules	oral

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-07-01
• Completion: 2019-05-01
• First posted: 2014-04-21
• Last updated: 2020-06-26

Locations

2 sites across 1 country: Canada