Actively Recruiting
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Led by Collegium Medicum w Bydgoszczy · Updated on 2024-08-27
200
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metabolic syndrome defined by obesity (waist circumference 88 cm in women; 102 cm or BMI 30 kg/m2) plus two of the following: high blood pressure (systolic 130 mm Hg or diastolic 85 mm Hg or on antihypertensive 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 treatment), elevated non-HDL cholesterol ( 130 mg/dL or on lipid-lowering treatment)
You will not qualify if you...
- Current treatment with SGLT2 inhibitor
- Chronic kidney disease with eGFR < 30 mL/min or on dialysis
- Severely impaired liver function
- Known hypersensitivity to empagliflozin or any excipients 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 less than 1 year
- Non-cooperative patients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Cuiavian-Pomeranian, Poland, 85-094
Actively Recruiting
Research Team
J
Jacek Kubica, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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