Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study
Collegium Medicum w Bydgoszczy
200 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-labled, investigator-initiated clinical trial with a 6 month follow-up. The study population will include 200 subjects with diagnosis of metabolic syndrome. All enrolled patients (nn=200) will be randomly assigned in 1:1 ratio to one of the two study arms: 1. Empagliflozin 20 mg - experimental arm 2. Empagliflozin 10 mg - control arm. Primary co-endpoints of the study include: BMI and HbA1c. Secondary endpoints include: LDL-C, triglycerides, CRP, NT-proBNP, LVEF (echocardiography), body composition, VO2max (ergospirometry), waist-hip ratio (WHR), liver steatosis assessment (LSA) by computed tomography (CT), major adverse cardiovascular events - MACE (based on medical history: heart attack, stroke, death), cardiovascular hospitalizations.
Eligibility
Inclusion Criteria4
- 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 Criteria14
- 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
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Interventions
Patients receiving empagliflozin 20 mg daily - experimental arm
Patients receiving empagliflozin 10 mg daily - control arm
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05905965