Actively Recruiting

Age: 2Years - 16Years
All Genders
Healthy Volunteers
NCT07483879

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

Led by Aristotle University Of Thessaloniki · Updated on 2026-03-19

45

Participants Needed

1

Research Sites

246 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 to 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
  • Age-matched healthy children without diabetes (for control group)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hippokration General Hospital of Thessaloniki

Thessaloniki, Central Makedonia, Greece

Actively Recruiting

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Research Team

A

Athina Stamati

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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