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RecruitingNCT07483879

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

Sponsor

Aristotle University Of Thessaloniki

Enrollment

45 participants

Start Date

Jun 13, 2025

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes MellitusDiabetic Ketoacidosis

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

Min Age: 2 YearsMax Age: 16 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

Interventions

DIAGNOSTIC_TESTBiomarker 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.

Locations(1)

Hippokration General Hospital of Thessaloniki

Thessaloniki, Central Makedonia, Greece

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NCT07483879

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