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 Mellitus Diabetic 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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether certain blood markers (biomarkers) can detect early damage to organs like the heart and kidneys in children who are newly diagnosed with type 1 diabetes. Some children with type 1 diabetes develop a dangerous complication called diabetic ketoacidosis (DKA) at diagnosis, and researchers want to understand whether this causes organ stress that can be detected through blood tests. **You may be eligible if...** - Your child is aged 2–16 years - Your child has just been diagnosed with type 1 diabetes - Your child is being admitted to hospital for initial evaluation and treatment - You (as parent or guardian) can provide written informed consent A healthy control group of children without diabetes is also being recruited for comparison. **You may NOT be eligible if...** - Your child was previously diagnosed with diabetes - Your child has chronic kidney disease - Your child has cardiovascular disease - Your child has an acute infection or inflammatory condition unrelated to diabetes - Your child takes medications that could affect kidney or heart biomarkers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.