Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
- Conditions
- Metabolic Syndrome
- Interventions
- Registration Number
- NCT05905965
- Lead Sponsor
- Collegium Medicum w Bydgoszczy
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin 20 mg Empagliflozin 20 mg Patients receiving empagliflozin 20 mg daily Empagliflozin 10 mg Empagliflozin 10 mg Patients receiving empagliflozin 10 mg daily
- Primary Outcome Measures
Name Time Method concentration of HbA1c (glycated hemoglobin) 0-6 months change in glycated hemoglobin plasma concentration between study arms
BMI (Body Mass Index) 0-6 months change in BMI between study arms
- Secondary Outcome Measures
Name Time Method concentration of NT-proBNP 0-6 months change in NT-pro BNP serum concentration between study arms
LVEF - left ventricle ejection fraction (echocardiography) 0-6 months change in LVEF (presented in percentage) between study arms
liver steatosis assessment (LSA) by computed tomography (CT) 0-6 months evaluation of liver steatosis assessment (LSA) assessed with computed tomography (CT), between study arms throughout the study
body composition analysis - total body water [%] 0-6 months evaluation of total body water \[%\] change throughout the study
cardiovascular hospitalizations 0-6 months rate of cardiovascular hospitalizations between study arms
body composition analysis - lean body mass [%] 0-6 months evaluation of lean body mass \[%\] change throughout the study
body composition analysis - extracellular water [liters] 0-6 months evaluation of extracellular water \[liters\] change throughout the study
concentration of CRP (c-reactive protein) 0-6 months change in CRP serum concentration between study arms
body composition analysis - body fat mass [%] 0-6 months evaluation of body fat mass \[%\] change throughout the study
body composition analysis - extracellular water [%] 0-6 months evaluation of extracellular water \[%\] change throughout the study
body composition analysis - hydration [%] 0-6 months evaluation of hydration \[%\] change throughout the study
concentration of LDL-C (low density cholesterol serum concentration) 0-6 months change in low density cholesterol serum concentration between study arms
concentration of triglycerides 0-6 months change in triglycerides serum concentration between study arms
body composition analysis - body fat mass [kg] 0-6 months evaluation of body fat mass \[kg\] change throughout the study
body composition analysis - lean body mass [kg] 0-6 months evaluation of lean body mass \[kg\] change throughout the study
body composition analysis - skeletal muscle mass [kg] 0-6 months evaluation of skeletal muscle mass \[kg\] change throughout the study
body composition analysis - total body water [liters] 0-6 months evaluation of total body water \[liters\] change throughout the study
body composition analysis - visceral fat level [liters] 0-6 months evaluation of visceral fat level \[liters\] change throughout the study
level of maximal oxygen uptake (VO2max) measured in ergospirometry 0-6 months change in VO2 max between study arms
major adverse cardiovascular events - MACE 0-6 months rate of MACE (based on medical history: heart attack, stroke, death) between study arms throughout the study
waist-hip ratio (WHR) 0-6 months change in waist-hip ratio between study arms
Trial Locations
- Locations (1)
Cardiology Department, Dr. A. Jurasz University Hospital
🇵🇱Bydgoszcz, Cuiavian-Pomeranian, Poland