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Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Sponsor: Collegium Medicum w Bydgoszczy
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.
Official title: Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-05-01
Completion Date
2026-03-31
Last Updated
2024-08-27
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin 20 mg
Patients receiving empagliflozin 20 mg daily - experimental arm
Empagliflozin 10 mg
Patients receiving empagliflozin 10 mg daily - control arm
Locations (1)
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Cuiavian-Pomeranian, Poland