A Phase 3 interventional study of Empagliflozin 20 mg and Empagliflozin 10 mg in Metabolic Syndrome, sponsored by Collegium Medicum w Bydgoszczy. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Collegium Medicum w Bydgoszczy · Phase 3, Interventional, and Treatment
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:
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:
Primary co-endpoints of the study include: BMI and HbA1c.
Secondary endpoints include:
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).
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Collegium Medicum w Bydgoszczy is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or (BMI) ≥30 kg/m2) and two of the three following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving empagliflozin 20 mg daily
Drug: Empagliflozin 20 mg
Patients receiving empagliflozin 10 mg daily
Drug: Empagliflozin 10 mg
Patients receiving empagliflozin 20 mg daily - experimental arm
Patients receiving empagliflozin 10 mg daily - control arm
BMI (Body Mass Index)
change in BMI between study arms
Time frame: 0-6 months
concentration of HbA1c (glycated hemoglobin)
change in glycated hemoglobin plasma concentration between study arms
Time frame: 0-6 months
concentration of LDL-C (low density cholesterol serum concentration)
change in low density cholesterol serum concentration between study arms
Time frame: 0-6 months
concentration of triglycerides
change in triglycerides serum concentration between study arms
Time frame: 0-6 months
concentration of CRP (c-reactive protein)
change in CRP serum concentration between study arms
Time frame: 0-6 months
concentration of NT-proBNP
change in NT-pro BNP serum concentration between study arms
Time frame: 0-6 months
LVEF - left ventricle ejection fraction (echocardiography)
change in LVEF (presented in percentage) between study arms
Time frame: 0-6 months
body composition analysis - body fat mass [kg]
evaluation of body fat mass \[kg\] change throughout the study
Time frame: 0-6 months
body composition analysis - body fat mass [%]
evaluation of body fat mass \[%\] change throughout the study
Time frame: 0-6 months
body composition analysis - lean body mass [kg]
evaluation of lean body mass \[kg\] change throughout the study
Time frame: 0-6 months
body composition analysis - lean body mass [%]
evaluation of lean body mass \[%\] change throughout the study
Time frame: 0-6 months
body composition analysis - skeletal muscle mass [kg]
evaluation of skeletal muscle mass \[kg\] change throughout the study
Time frame: 0-6 months
body composition analysis - total body water [liters]
evaluation of total body water \[liters\] change throughout the study
Time frame: 0-6 months
body composition analysis - total body water [%]
evaluation of total body water \[%\] change throughout the study
Time frame: 0-6 months
body composition analysis - extracellular water [liters]
evaluation of extracellular water \[liters\] change throughout the study
Time frame: 0-6 months
body composition analysis - extracellular water [%]
evaluation of extracellular water \[%\] change throughout the study
Time frame: 0-6 months
body composition analysis - hydration [%]
evaluation of hydration \[%\] change throughout the study
Time frame: 0-6 months
body composition analysis - visceral fat level [liters]
evaluation of visceral fat level \[liters\] change throughout the study
Time frame: 0-6 months
level of maximal oxygen uptake (VO2max) measured in ergospirometry
change in VO2 max between study arms
Time frame: 0-6 months
waist-hip ratio (WHR)
change in waist-hip ratio between study arms
Time frame: 0-6 months
liver steatosis assessment (LSA) by computed tomography (CT)
evaluation of liver steatosis assessment (LSA) assessed with computed tomography (CT), between study arms throughout the study
Time frame: 0-6 months
major adverse cardiovascular events - MACE
rate of MACE (based on medical history: heart attack, stroke, death) between study arms throughout the study
Time frame: 0-6 months
cardiovascular hospitalizations
rate of cardiovascular hospitalizations between study arms
Time frame: 0-6 months
Plan to share: No
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Studies of the drug tested here: Empagliflozin
Collegium Medicum w Bydgoszczy