CClinicalTrials.gg
Sign In
RecruitingNCT05905965DEMETERUpdated Aug 27, 2024

Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

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

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

  • Metabolic Syndrome

Keywords

  • metabolic syndrome
  • empagliflozin
  • adherence
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. 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;
    2. 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;
    3. elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Empagliflozin 20 mg

    Patients receiving empagliflozin 20 mg daily

    Drug: Empagliflozin 20 mg

  • Active comparator
    Empagliflozin 10 mg

    Patients receiving empagliflozin 10 mg daily

    Drug: Empagliflozin 10 mg

Interventions

  • DrugEmpagliflozin 20 mg

    Patients receiving empagliflozin 20 mg daily - experimental arm

  • DrugEmpagliflozin 10 mg

    Patients receiving empagliflozin 10 mg daily - control arm

05

What researchers measure

Primary outcomes

  1. BMI (Body Mass Index)

    change in BMI between study arms

    Time frame: 0-6 months

  2. concentration of HbA1c (glycated hemoglobin)

    change in glycated hemoglobin plasma concentration between study arms

    Time frame: 0-6 months

Secondary outcomes

  1. concentration of LDL-C (low density cholesterol serum concentration)

    change in low density cholesterol serum concentration between study arms

    Time frame: 0-6 months

  2. concentration of triglycerides

    change in triglycerides serum concentration between study arms

    Time frame: 0-6 months

  3. concentration of CRP (c-reactive protein)

    change in CRP serum concentration between study arms

    Time frame: 0-6 months

  4. concentration of NT-proBNP

    change in NT-pro BNP serum concentration between study arms

    Time frame: 0-6 months

  5. LVEF - left ventricle ejection fraction (echocardiography)

    change in LVEF (presented in percentage) between study arms

    Time frame: 0-6 months

  6. body composition analysis - body fat mass [kg]

    evaluation of body fat mass \[kg\] change throughout the study

    Time frame: 0-6 months

  7. body composition analysis - body fat mass [%]

    evaluation of body fat mass \[%\] change throughout the study

    Time frame: 0-6 months

  8. body composition analysis - lean body mass [kg]

    evaluation of lean body mass \[kg\] change throughout the study

    Time frame: 0-6 months

  9. body composition analysis - lean body mass [%]

    evaluation of lean body mass \[%\] change throughout the study

    Time frame: 0-6 months

  10. body composition analysis - skeletal muscle mass [kg]

    evaluation of skeletal muscle mass \[kg\] change throughout the study

    Time frame: 0-6 months

  11. body composition analysis - total body water [liters]

    evaluation of total body water \[liters\] change throughout the study

    Time frame: 0-6 months

  12. body composition analysis - total body water [%]

    evaluation of total body water \[%\] change throughout the study

    Time frame: 0-6 months

  13. body composition analysis - extracellular water [liters]

    evaluation of extracellular water \[liters\] change throughout the study

    Time frame: 0-6 months

  14. body composition analysis - extracellular water [%]

    evaluation of extracellular water \[%\] change throughout the study

    Time frame: 0-6 months

  15. body composition analysis - hydration [%]

    evaluation of hydration \[%\] change throughout the study

    Time frame: 0-6 months

  16. body composition analysis - visceral fat level [liters]

    evaluation of visceral fat level \[liters\] change throughout the study

    Time frame: 0-6 months

  17. level of maximal oxygen uptake (VO2max) measured in ergospirometry

    change in VO2 max between study arms

    Time frame: 0-6 months

  18. waist-hip ratio (WHR)

    change in waist-hip ratio between study arms

    Time frame: 0-6 months

  19. 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

  20. 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

  21. cardiovascular hospitalizations

    rate of cardiovascular hospitalizations between study arms

    Time frame: 0-6 months

06

Study locations

1 of 1 sites recruiting
  • Cardiology Department, Dr. A. Jurasz University Hospital
    Bydgoszcz, Cuiavian-Pomeranian 85-094, Poland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05905965
Lead sponsor
Collegium Medicum w Bydgoszczy
Responsible party
Jacek Kubica (Prof. dr hab., Collegium Medicum w Bydgoszczy) — Principal investigator
First posted
Jun 15, 2023
Start date
May 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Aug 27, 2024

Study contacts

Jacek Kubica, Prof.
Contact
jkubica@cm.umk.pl
+48 525854023
Jacek Kubica, Prof.
principal investigator · Collegium Medicum w Bydgoszczy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Metabolic Syndrome→

Other studies from this sponsor

Collegium Medicum w Bydgoszczy

Start the discussion