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Carnitine for the Treatment of Atherosclerosis.

NCT02117661 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2020-06-26

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

L-carnitine capsules

Oral

DIETARY_SUPPLEMENT

Cellulose capsules

oral

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Queen's University

    collaborator OTHER

  • Dr. Amer Johri

    lead OTHER

Principal Investigators

  • Amer M Johri, MD · Queen's University

  • J.David Spence, MD · Robarts Institute

  • Daren K Heyland, MD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-07-31
Completion
2019-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117661 on ClinicalTrials.gov