Carnitine for the Treatment of Atherosclerosis. (ECoM)

This is an interventional treatment trial for Metabolic Syndrome focused on measuring L-carnitine, Metabolic syndrome, Atherosclerosis, Coronary artery disease, Carotid, Plaque, Cardiovascular disease, Heart disease, Vascular disease Read More

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.

1. 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:

   1. Elevated waist circumference: Population- and country-specific definitions; Health Canada recommends males 102 cm and women 88cm.
   2. Elevated triglycerides: 150 mg/dL (1.7 mmol/L).
   3. Reduced HDL: 40 mg/dL (1.0 mmol/L) in males; 50 mg/dL (1.3 mmol/L) in females or treated.
   4. Elevated BP: Systolic 130 and/or diastolic 85 mm Hg or treated.
   5. Elevated fasting glucose: 100 mg/dL (5.6 mmol/L), or HbA1c ≥6.2%, or treated.
2. 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:

1. Individuals who have had a change in statin and/or diabetes medication therapy or dosing in the last three months;
2. 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);
3. Known severe abnormal blood biochemistries: Na <100 or >150 mmol/L, K <2 or >5 mmol/L, Total Serum Ca >3 mmol/L;
4. Known severe liver disease: AST >100 U/L, ALT >80 U/L, or a diagnosis of cirrhosis (Child Pugh Class A to C);
5. Known severe anemia: HgB <70 g/L;
6. Have endocrine disorders, e.g. Cushing's disease, hyper- or hypo-thyroidism;
7. Any condition expected to limit survival to less than six (6) months (ex. malignant tumor);
8. A condition limiting adherence to study procedure (i.e. alcoholism, drug addiction, known poor adherence, severe mental disorder);
9. 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;
10. 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);
11. Currently pregnant or breastfeeding;
12. A history of allergy or intolerance to L-C or derivatives;
13. Vegetarians (do not eat animal flesh) due to potential for altered L-C metabolism;
14. Patients who have had a carotid surgery (ie. endarterectomy (CEA) or stent) or who are scheduled to receive carotid surgery during the trial.