Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER)
Metabolic Syndrome
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, empagliflozin, adherence
Eligibility Criteria
Inclusion Criteria: diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or body mass index (BMI) ≥30 kg/m2) and two of the three following criteria: high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and/or diastolic blood pressure ≥85 mm Hg or systolic blood pressure - ambulatory measurement: ≥130 and/or diastolic blood pressure ≥ 80 mm Hg) or on anti-hypertensive treatment; impaired glucose metabolism (fasting glucose ≥100 mg/dL or ≥ 140 mg/dL after 120 min in oral glucose tolerance test or HbA1c ≥5.7%) or on glucose-lowering drug treatment; elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment Exclusion Criteria: current treatment with SGLT2 inhibitor chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 mL/min or on dialysis severely impaired liver function known hypersensitivity to the active empagliflozin or to any of the excipients contained in Jardiance history of ketoacidosis diabetes treated with insulin pregnancy decompensated heart failure acute coronary syndrome active thromboembolic disease current treatment for neoplastic disease active inflammatory disease within 1 month prior to enrollment expected lifetime <1 year non-cooperative patients
Sites / Locations
- Cardiology Department, Dr. A. Jurasz University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Empagliflozin 20 mg
Empagliflozin 10 mg
Patients receiving empagliflozin 20 mg daily
Patients receiving empagliflozin 10 mg daily