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Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER)

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Empagliflozin 20 mg
Empagliflozin 10 mg
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, empagliflozin, adherence

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 Exclusion Criteria: current treatment with SGLT2 inhibitor chronic kidney disease with estimated glomerular filtration rate (eGFR) &lt; 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

Sites / Locations

  • Cardiology Department, Dr. A. Jurasz University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Empagliflozin 20 mg

Empagliflozin 10 mg

Arm Description

Patients receiving empagliflozin 20 mg daily

Patients receiving empagliflozin 10 mg daily

Outcomes

Primary Outcome Measures

BMI (Body Mass Index)
change in BMI between study arms
concentration of HbA1c (glycated hemoglobin)
change in glycated hemoglobin plasma concentration between study arms

Secondary Outcome Measures

concentration of LDL-C (low density cholesterol serum concentration)
change in low density cholesterol serum concentration between study arms
concentration of triglycerides
change in triglycerides serum concentration between study arms
concentration of CRP (c-reactive protein)
change in CRP serum concentration between study arms
concentration of NT-proBNP
change in NT-pro BNP serum concentration between study arms
LVEF - left ventricle ejection fraction (echocardiography)
change in LVEF (presented in percentage) between study arms
body composition analysis - body fat mass [kg]
evaluation of body fat mass [kg] change throughout the study
body composition analysis - body fat mass [%]
evaluation of body fat mass [%] change throughout the study
body composition analysis - lean body mass [kg]
evaluation of lean body mass [kg] change throughout the study
body composition analysis - lean body mass [%]
evaluation of lean body mass [%] change throughout the study
body composition analysis - skeletal muscle mass [kg]
evaluation of skeletal muscle mass [kg] change throughout the study
body composition analysis - total body water [liters]
evaluation of total body water [liters] change throughout the study
body composition analysis - total body water [%]
evaluation of total body water [%] change throughout the study
body composition analysis - extracellular water [liters]
evaluation of extracellular water [liters] change throughout the study
body composition analysis - extracellular water [%]
evaluation of extracellular water [%] change throughout the study
body composition analysis - hydration [%]
evaluation of hydration [%] change throughout the study
body composition analysis - visceral fat level [liters]
evaluation of visceral fat level [liters] change throughout the study
level of maximal oxygen uptake (VO2max) measured in ergospirometry
change in VO2 max between study arms
waist-hip ratio (WHR)
change in waist-hip ratio between study arms
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
major adverse cardiovascular events - MACE
rate of MACE (based on medical history: heart attack, stroke, death) between study arms throughout the study
cardiovascular hospitalizations
rate of cardiovascular hospitalizations between study arms

Full Information

First Posted
May 12, 2023
Last Updated
June 13, 2023
Sponsor
Collegium Medicum w Bydgoszczy
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1. Study Identification

Unique Protocol Identification Number
NCT05905965
Brief Title
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Acronym
DEMETER
Official Title
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Empagliflozin 20 mg - experimental arm 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: Empagliflozin 20 mg - experimental arm 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, empagliflozin, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin 20 mg
Arm Type
Experimental
Arm Description
Patients receiving empagliflozin 20 mg daily
Arm Title
Empagliflozin 10 mg
Arm Type
Active Comparator
Arm Description
Patients receiving empagliflozin 10 mg daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 20 mg
Intervention Description
Patients receiving empagliflozin 20 mg daily - experimental arm
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 mg
Intervention Description
Patients receiving empagliflozin 10 mg daily - control arm
Primary Outcome Measure Information:
Title
BMI (Body Mass Index)
Description
change in BMI between study arms
Time Frame
0-6 months
Title
concentration of HbA1c (glycated hemoglobin)
Description
change in glycated hemoglobin plasma concentration between study arms
Time Frame
0-6 months
Secondary Outcome Measure Information:
Title
concentration of LDL-C (low density cholesterol serum concentration)
Description
change in low density cholesterol serum concentration between study arms
Time Frame
0-6 months
Title
concentration of triglycerides
Description
change in triglycerides serum concentration between study arms
Time Frame
0-6 months
Title
concentration of CRP (c-reactive protein)
Description
change in CRP serum concentration between study arms
Time Frame
0-6 months
Title
concentration of NT-proBNP
Description
change in NT-pro BNP serum concentration between study arms
Time Frame
0-6 months
Title
LVEF - left ventricle ejection fraction (echocardiography)
Description
change in LVEF (presented in percentage) between study arms
Time Frame
0-6 months
Title
body composition analysis - body fat mass [kg]
Description
evaluation of body fat mass [kg] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - body fat mass [%]
Description
evaluation of body fat mass [%] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - lean body mass [kg]
Description
evaluation of lean body mass [kg] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - lean body mass [%]
Description
evaluation of lean body mass [%] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - skeletal muscle mass [kg]
Description
evaluation of skeletal muscle mass [kg] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - total body water [liters]
Description
evaluation of total body water [liters] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - total body water [%]
Description
evaluation of total body water [%] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - extracellular water [liters]
Description
evaluation of extracellular water [liters] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - extracellular water [%]
Description
evaluation of extracellular water [%] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - hydration [%]
Description
evaluation of hydration [%] change throughout the study
Time Frame
0-6 months
Title
body composition analysis - visceral fat level [liters]
Description
evaluation of visceral fat level [liters] change throughout the study
Time Frame
0-6 months
Title
level of maximal oxygen uptake (VO2max) measured in ergospirometry
Description
change in VO2 max between study arms
Time Frame
0-6 months
Title
waist-hip ratio (WHR)
Description
change in waist-hip ratio between study arms
Time Frame
0-6 months
Title
liver steatosis assessment (LSA) by computed tomography (CT)
Description
evaluation of liver steatosis assessment (LSA) assessed with computed tomography (CT), between study arms throughout the study
Time Frame
0-6 months
Title
major adverse cardiovascular events - MACE
Description
rate of MACE (based on medical history: heart attack, stroke, death) between study arms throughout the study
Time Frame
0-6 months
Title
cardiovascular hospitalizations
Description
rate of cardiovascular hospitalizations between study arms
Time Frame
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Exclusion Criteria: current treatment with SGLT2 inhibitor chronic kidney disease with estimated glomerular filtration rate (eGFR) &lt; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Kubica, Prof.
Phone
+48 525854023
Email
jkubica@cm.umk.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Kubica, Prof.
Organizational Affiliation
Collegium Medicum w Bydgoszczy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department, Dr. A. Jurasz University Hospital
City
Bydgoszcz
State/Province
Cuiavian-Pomeranian
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Kubica, prof.
Phone
+48525854023
Email
jkubica@cm.umk.pl

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

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