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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorAristotle University Of Thessaloniki

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Previous diagnosis of diabetes mellitus

Known chronic kidney disease

Known cardiovascular disease

Acute infection or inflammatory condition unrelated to diabetes

Trial design

Treatments tested in this trial

  • Biomarker and Echocardiographic Assessment

Treatment groups

45 Participants
are divided into 3 treatment groups