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Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes

Recruitingn/aAges 2 Years - 16 YearsAllAristotle University Of Thessaloniki
NCT07483879 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. This 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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children aged 2-16 years * Newly diagnosed type 1 diabetes mellitus * Hospital admission for initial evaluation and treatment * Presence or absence of diabetic ketoacidosis at diagnosis * Written informed consent from parents or legal guardians For control group: \- Age-matched healthy children without diabetes Exclusion Criteria: * Previous diagnosis of diabetes mellitus * Known chronic kidney disease * Known cardiovascular disease * Acute infection or inflammatory condition unrelated to diabetes * Use of medications that may affect renal or cardiac biomarkers
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What it tests

  • Biomarker and Echocardiographic Assessment
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Where

1 site
Hippokration General Hospital of Thessaloniki
Thessaloniki, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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