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Compares treatment options for Metabolic Syndrome
Official title Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
ClinicalTrials.gov ID: NCT05905965
What this study is testing
What is Empagliflozin 20 mg?
Empagliflozin 20 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for metabolic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or body mass index (BMI) ≥30...
- high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and/or diastolic blood pressure ≥85 mm Hg or systolic blood pressure -...
- 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...
- elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment
You likely can't join if
- 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
See the full eligibility 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bydgoszcz, Cuiavian-Pomeranian, Poland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bydgoszcz, Cuiavian-Pomeranian, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.