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

RECRUITINGSponsored by Aristotle University Of Thessaloniki
Actively Recruiting
SponsorAristotle University Of Thessaloniki
Started2025-06-13
Est. completion2029-12
Eligibility
Age2 Years – 16 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 2 Years – 16 YearsHealthy volunteers accepted
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

Conditions4

DiabetesDiabetic KetoacidosisHeart DiseaseType 1 Diabetes Mellitus

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