Condition: Metabolic Syndrome · Sponsor: Collegium Medicum w Bydgoszczy
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.
This description comes directly from the study's public registry record.
Jacek Kubica, Prof. · +48 525854023 · jkubica@cm.umk.pl
Always discuss trial participation with your own doctor first.
| Cardiology Department, Dr. A. Jurasz University Hospital | Bydgoszcz, Cuiavian-Pomeranian, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05905965