NCT05905965

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Collegium Medicum w Bydgoszczy · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Other variables that are scheduled to be analyzed: central arterial pressure, pulse wave propagation speed, ABPM (ambulatory blood pressure monitoring), endothelial function assessment by Endopath, autonomic nervous system assessment (ANSA) by Task Force Touch CARDIO (TFTC), exercise tolerance, thickness of the adipose tissue (skin fold), blood samples: blood count, serum creatinine and eGFR, ALT, AST, GGTP, total cholesterol, HDL-C, uric acid, plasma concentration of calcium, phosphate, parathormon, 25-OH-D3, cystatin C, erythropoietin; morning urine: N-acetyl-beta-D-glucosaminidase, sodium/creatinine ratio, calcium/creatinine ratio, albumin/creatinine ratio. Moreover, functioning in chronic disease and adherence to medication and diet will be assessed with dedicated questionairies (FCIS, ACDS, ACDS diet).

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Empagliflozin 20 mg	Patients receiving empagliflozin 20 mg daily - experimental arm
DRUG	Empagliflozin 10 mg	Patients receiving empagliflozin 10 mg daily - control arm

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2023-06-15
• Last updated: 2024-08-27

Locations

1 site across 1 country: Poland