Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT02117661
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02117661
Study Brief:
Protocol Section:
NCT02117661