- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117661
Carnitine for the Treatment of Atherosclerosis. (ECoM)
ECoM Study: Effect of Carnitine Supplementation on Progression of Carotid Plaque in the Metabolic Syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital
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London, Ontario, Canada, N6G 2V2
- Robarts Institute, Stroke Prevention & Atherosclerosis Research Centre (SPARC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Population: Patients, followed in our clinics for cardiovascular disease (CVD) prevention, fulfilling diagnosis criteria for metabolic syndrome (MetS) will be recruited. Eligibility will require a 2 step process as described.
Inclusion Criteria:
STEP 1: Initial screening; BP, weight and fasting blood samples will be obtained.
Men and women, >18 years, meeting the criteria for clinical diagnosis of MetS, according to the International Diabetes Federation (IDF) harmonized definition, where any 3 of the 5 following risk factors cut points constitutes a diagnosis of MetS:
- Elevated waist circumference: Population- and country-specific definitions; Health Canada recommends males 102 cm and women 88cm.
- Elevated triglycerides: 150 mg/dL (1.7 mmol/L).
- Reduced HDL: 40 mg/dL (1.0 mmol/L) in males; 50 mg/dL (1.3 mmol/L) in females or treated.
- Elevated BP: Systolic 130 and/or diastolic 85 mm Hg or treated.
- Elevated fasting glucose: 100 mg/dL (5.6 mmol/L), or HbA1c ≥6.2%, or treated.
- Willing to provide informed consent. STEP 2: Baseline plaque volume ≥50 mm3 by 3D US, to ensure sufficient detectable plaque. This will be measured after consent (at Step 1), but prior to randomization/enrolment (Step 2).
Exclusion criteria:
- Individuals who have had a change in statin and/or diabetes medication therapy or dosing in the last three months;
- Who are actively having an unstable arrhythmia, angina or heart attack (untreated and/or unstable patients): symptomatic heart failure (NYHA 2 or greater); renal failure (GFR <50 mL/min/1.73m2);
- Known severe abnormal blood biochemistries: Na <100 or >150 mmol/L, K <2 or >5 mmol/L, Total Serum Ca >3 mmol/L;
- Known severe liver disease: AST >100 U/L, ALT >80 U/L, or a diagnosis of cirrhosis (Child Pugh Class A to C);
- Known severe anemia: HgB <70 g/L;
- Have endocrine disorders, e.g. Cushing's disease, hyper- or hypo-thyroidism;
- Any condition expected to limit survival to less than six (6) months (ex. malignant tumor);
- A condition limiting adherence to study procedure (i.e. alcoholism, drug addiction, known poor adherence, severe mental disorder);
- Concomitant treatment with: anticonvulsants; L-C or derivatives; Acenocoumarol (Sintrom) and Warfarin (Coumadin) anticoagulants and vitamin K antagonists; >1g fish oil; and/or thyroid treatment;
- A seizure disorder or at risk of seizure (CNS mass or medications that lower seizure threshold); receiving treatments for cancer or HIV infection (secondary L-C deficiency);
- Currently pregnant or breastfeeding;
- A history of allergy or intolerance to L-C or derivatives;
- Vegetarians (do not eat animal flesh) due to potential for altered L-C metabolism;
- Patients who have had a carotid surgery (ie. endarterectomy (CEA) or stent) or who are scheduled to receive carotid surgery during the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: L-carnitine capsules
2000 mg daily (2x 500 mg capsules twice a day - BID) for six months
|
Oral
Other Names:
|
Placebo Comparator: Cellulose capsules
2x capsules twice a day - BID (4 total per day) for six months
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in carotid Total Plaque Volume
Time Frame: Six months
|
Carotid 3D ultrasound scan
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in LDL size profile
Time Frame: Six months
|
Blood test
|
Six months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: J.David Spence, MD, Robarts Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- L-Carnitine-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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