[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508864":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Collegium Medicum w Bydgoszczy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin 20 mg","EXPERIMENTAL","Patients receiving empagliflozin 20 mg daily",[13],"Drug: Empagliflozin 20 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Empagliflozin 10 mg","ACTIVE_COMPARATOR","Patients receiving empagliflozin 10 mg daily",[19],"Drug: Empagliflozin 10 mg",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients receiving empagliflozin 20 mg daily - experimental arm",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients receiving empagliflozin 10 mg daily - control arm",[15],[30],{"name":31,"affiliation":5,"role":32},"Jacek Kubica, Prof.","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+48 525854023","jkubica@cm.umk.pl",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Cardiology Department, Dr. A. Jurasz University Hospital","RECRUITING","Bydgoszcz","Cuiavian-Pomeranian","85-094","Poland","PL",{"type":48,"coordinates":49},"Point",[50,51],18.00762,53.1235,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":25,"email":37},"Jacek Kubica, prof.","+48525854023",{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jacek Kubica","Prof. dr hab.","100508864","phase-3-efficacy-of-double-vs-standard-empapagliflozin-dose-for-metabolic-syndrome-treatment-100508864",false,"NCT05905965","Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment","Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study","DEMETER","Inclusion Criteria:\n\n* 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\u002Fm2) and two of the three following criteria:\n\n  1. high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and\u002For diastolic blood pressure ≥85 mm Hg or systolic blood pressure - ambulatory measurement: ≥130 and\u002For diastolic blood pressure ≥ 80 mm Hg) or on anti-hypertensive treatment;\n  2. impaired glucose metabolism (fasting glucose ≥100 mg\u002FdL or ≥ 140 mg\u002FdL after 120 min in oral glucose tolerance test or HbA1c ≥5.7%) or on glucose-lowering drug treatment;\n  3. elevated non-high-density lipoprotein (non-HDL ≥130 mg\u002FdL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment\n\nExclusion Criteria:\n\n* current treatment with SGLT2 inhibitor\n* chronic kidney disease with estimated glomerular filtration rate (eGFR) \\< 30 mL\u002Fmin or on dialysis\n* severely impaired liver function\n* known hypersensitivity to the active empagliflozin or to any of the excipients contained in Jardiance\n* history of ketoacidosis\n* diabetes treated with insulin\n* pregnancy\n* decompensated heart failure\n* acute coronary syndrome\n* active thromboembolic disease\n* current treatment for neoplastic disease\n* active inflammatory disease within 1 month prior to enrollment\n* expected lifetime \\\u003C1 year\n* non-cooperative patients","ALL","18 Years","85 Years",{"count":72,"type":73},200,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-labled, investigator-initiated clinical trial with a 6 month follow-up.\n\nThe study population will include 200 subjects with diagnosis of metabolic syndrome.\n\nAll enrolled patients (nn=200) will be randomly assigned in 1:1 ratio to one of the two study arms:\n\n1. Empagliflozin 20 mg - experimental arm\n2. 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.",[79],"Metabolic Syndrome",[81,82,83],"metabolic syndrome","empagliflozin","adherence","2024-08-26",{"date":86,"type":87},"2024-08-27","ACTUAL",{"date":89,"type":87},"2023-05-01",{"date":91,"type":73},"2026-03-31",{"name":5,"class":6},1]