[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630146":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Aristotle University Of Thessaloniki","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Newly Diagnosed T1DM with DKA",null,"Children with newly diagnosed type 1 diabetes mellitus presenting with diabetic ketoacidosis at hospital admission.",[13],"Diagnostic Test: Biomarker and Echocardiographic Assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Newly Diagnosed T1DM without DKA","Children with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Healthy Controls","Age-matched healthy children without diabetes serving as the control group.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Biomarker and Echocardiographic Assessment","Blood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes.",[19,9,15],[29],{"name":30,"affiliation":5,"role":31},"Athanasios Christoforidis","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Athina Stamati","CONTACT","+30 6958796612","atstamati@gmail.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hippokration General Hospital of Thessaloniki","RECRUITING","Thessaloniki","Central Makedonia","Greece","GR",{"type":47,"coordinates":48},"Point",[49,50],22.93493,40.64072,{"lat":50,"lon":49},[53,54],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"type":31,"investigatorFullName":30,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Professor of Pediatrics - Pediatric Endocrinology","100630146","biomarkers-of-acute-organ-injury-in-pediatric-newly-diagnosed-type-1-diabetes-100630146",false,"NCT07483879","Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes","Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis","Inclusion Criteria:\n\n* Children aged 2-16 years\n* Newly diagnosed type 1 diabetes mellitus\n* Hospital admission for initial evaluation and treatment\n* Presence or absence of diabetic ketoacidosis at diagnosis\n* Written informed consent from parents or legal guardians\n\nFor control group:\n\n\\- Age-matched healthy children without diabetes\n\nExclusion Criteria:\n\n* Previous diagnosis of diabetes mellitus\n* Known chronic kidney disease\n* Known cardiovascular disease\n* Acute infection or inflammatory condition unrelated to diabetes\n* Use of medications that may affect renal or cardiac biomarkers",true,"ALL","2 Years","16 Years",{"count":69,"type":70},45,"ESTIMATED","OBSERVATIONAL","Diabetic ketoacidosis (DKA) is a severe metabolic complication in children with newly diagnosed type 1 diabetes mellitus (T1DM) and may be associated with early injury of vital organs such as the kidneys and the heart. Early detection of organ dysfunction is important for identifying children at increased risk for complications.\n\nThis observational cross-sectional study aims to evaluate biomarkers of acute organ injury and associated clinical and echocardiographic parameters in children with newly diagnosed T1DM presenting with DKA, compared with children with newly diagnosed T1DM without DKA and healthy controls. Biomarkers including KIM-1, NGAL, high-sensitivity troponin, NT-proBNP, interleukin-6, and C-reactive protein will be measured during hospital admission and within the first 24-48 hours of hospitalization.",[74,75],"Type 1 Diabetes Mellitus","Diabetic Ketoacidosis",[77,78,79,80,81,82,83,84,85],"Biomarkers","Acute Kidney Injury","Cardiac Biomarkers","NGAL","NT-proBNP","hs-Troponin","Pediatric Type 1 Diabetes","Myocardial Strain Imaging","KIM-1","2026-03-17",{"date":88,"type":89},"2026-03-19","ACTUAL",{"date":91,"type":89},"2025-06-13",{"date":93,"type":70},"2030-03",{"name":5,"class":6},1]