[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353194":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":40,"locations":49,"responsibleParty":67,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":10,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Athens","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"GLP1 and SGLT2i group",null,"60 patients treated with a combination of liraglutide and empagliflozin. All subjects will undergo an echocardiographic study to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using Sideview Darkfield Imaging (Microscan, Glycockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and lipid profile will be measured before and at 6 and 12 months of treatment.",{"label":13,"type":10,"description":14,"interventionNames":10},"GLP1 group","60 patients treated with liraglutide. All subjects will undergo an echocardiographic study in order to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using Sideview Darkfield Imaging (Microscan, Glycockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 6 and 12 months of treatment.",{"label":16,"type":10,"description":17,"interventionNames":10},"SGLT2i group","60 patients treated with empagliflozin. All subjects will undergo an echocardiographic study in order to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using Sideview Darkfield Imaging (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 6 and 12 months of treatment.",{"label":19,"type":10,"description":20,"interventionNames":10},"Control group","60 patients treated with insulin and metformin.All subjects will undergo an echocardiographic study in order to estimate GLS, left ventricular twisting-untwisting using speckle tracking imaging and carotid intima-media thickness. PWV, AIx, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of subglottic vessels using Sideview Darkfield Imaging (Microscan, Glucockeck). PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Oxidative stress markers, vascular cell adhesion molecule (VCAM)-1, intercellular adhesion molecule (ICAM)-1, thrombomodulin, nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP), growth differentiation factor (GDF)-15, mitochondrial-derived peptide-c (MOTS-c), blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 6 and 12 months of treatment.",[22,26,29,32,35,38],{"name":23,"affiliation":24,"role":25},"Ignatios Ikonomidis, Prof","2nd Department of Cardiology, National and Kapodistrian University of Athens","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Aimilianos N. Kalogeris, MD","2nd Department of Cardiology, University of Athens",{"name":30,"affiliation":31,"role":25},"John A. Thymis, MD","2nd Department of Cardiology,University of Athens",{"name":33,"affiliation":34,"role":25},"Vaia Lambadiari, Prof.","National and Kapodistrian University of Athens",{"name":36,"affiliation":34,"role":37},"Georgios Dimitriadis, Prof.","STUDY_CHAIR",{"name":39,"affiliation":34,"role":37},"Efstathios Iliodromitis, Prof.",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Ignatios Ikonomidis, Prof.","CONTACT","00306944805732","ignoik@gmail.com",{"name":27,"role":43,"phone":47,"phoneExt":10,"email":48},"00306949630300","kalogeris.cardio@gmail.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"\"Attikon\" University General Hospital","RECRUITING","Athens","Attica","12462","Greece","GR",{"type":59,"coordinates":60},"Point",[61,62],23.72784,37.98376,{"lat":62,"lon":61},[65],{"name":66,"role":25,"phone":10,"phoneExt":10,"email":10},"Ignatios Ikonomidis, MD",{"type":25,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ignatios Ikonomidis","Professor of Cardiology","100353194","the-cardiovascular-effect-of-glp-1-agonist-sglt2-inhibitor-and-their-combination-100353194",false,"NCT03878706","The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination","The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk","Inclusion Criteria:\n\n* Subject has type 2 diabetes mellitus\n* Subject has high or very high cardiovascular risk\n* Subject has heart failure with preserved ejection fraction\n\nExclusion Criteria:\n\n* Subject has type 1 diabetes mellitus\n* Subject has kidney disease\n* Subject has retinopathy","ALL","45 Years","80 Years",{"count":81,"type":82},240,"ESTIMATED","12 Months","OBSERVATIONAL","A. Four groups of patients with type 2 diabetes mellitus with high or very high cardiovascular risk or heart failure with preserved ejection fraction (HFpEF) will be studied before and at 6 and 12 months of treatment:\n\n* 60 patients treated with a combination of GLP1 analogue and SGLT2 inhibitor ± metformin\n* 60 patients treated with GLP-1 agonist as a second step after metformin\n* 60 patients treated with SGLT2 inhibitor as a second step after metformin\n* 60 patients treated with a combination of insulin and other antidiabetic agents (metformin - DPP4 inhibitors) Individuals will be equal distributed as far as age, gender and body mass index concerned. In addition, patients suffered from kidney disease and retinopathy are excluded.",[87],"Diabetes Mellitus, Type 2",[89,90,91,92,93,94,95],"Endothelial glycocalyx integrity","Oxidative stress biomarkers","Arterial stiffness","GLS","NT-proBNP","GDF-15","MOTS-c","2026-03-11",{"date":98,"type":99},"2026-03-13","ACTUAL",{"date":101,"type":99},"2017-11-03",{"date":103,"type":82},"2027-06-30",{"name":5,"class":6},1]