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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT02017561
Eligibility Criteria:
Inclusion Criteria:
* Non-diabetic adults aged between 40 and 64 years fulfilling the American Heart Association/National Heart, Lung and Blood Institute diagnostic criteria of metabolic syndrome (at least 3 of the following: waist circumference ≥102 cm (males) or ≥88 cm (females); fasting triglycerides≥150 mg/dL or on drug therapy for decreasing triglycerides; fasting HDL-cholesterol ˂40 mg/dL (males) or ˂50 mg/dL (females) or on drug therapy for increase HDL-c; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or on antihypertensive drug therapy; fasting glycemia≥100 mg/dL
* Echocardiographic evidence of left ventricle diastolic dysfunction at rest (mean E'˂10,2 cm/s if 40-59 years and ˂7,2 cm/s if 60-64 years).
Exclusion Criteria:
* diagnosis of diabetes mellitus according to the American Diabetes Association criteria;
* previous diagnosis of ischemic heart disease;
* moderate or severe cardiac valvular disease;
* left ventricle ejection fraction lower than 50%
* pericardial disease;
* uncontrolled atrial or ventricular tachyarrhythmias;
* chronic kidney disease (estimated creatinine clearance lower than 60 mL/min);
* significant liver disease (aspartate aminotransferase or alanine aminotransferase equal or above 2.5 times the upper limit of normal);
* females who are pregnant, planning to become pregnant or who admit sexual activity without appropriate contraception;
* lactation;
* unable to perform cardiopulmonary exercise test;
* recent (less than 1 month) change in drug therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
64 Years
Study:
NCT02017561
Study Brief:
Protocol Section:
NCT02017561