NCT07483879

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: 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.

Detailed description

Diabetic ketoacidosis (DKA) is a common and potentially life-threatening metabolic complication in children with newly diagnosed type 1 diabetes mellitus (T1DM). In addition to the acute metabolic disturbances, DKA may lead to early or subclinical injury of vital organs, particularly the kidneys and the cardiovascular system, due to dehydration, hypovolemia, metabolic acidosis, electrolyte disturbances, and inflammatory activation. Recent studies suggest that novel biomarkers may allow early detection of organ dysfunction before conventional clinical indicators become abnormal. Biomarkers such as kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, high-sensitivity troponin (hs-troponin), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) have been proposed as sensitive indicators of kidney and myocardial injury. Inflammatory markers such as interleukin-6 (IL-6) and C-reactive protein (CRP) may also reflect systemic inflammatory activation associated with metabolic decompensation. The aim of this observational cross-sectional study is to investigate and compare biomarkers of acute organ injury and related 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. Participants will be categorized into three groups: (1) children with newly diagnosed T1DM presenting with DKA, (2) children with newly diagnosed T1DM without DKA, and (3) healthy children serving as controls. Blood samples will be collected at hospital admission for measurement of biomarkers including KIM-1, NGAL, hs-troponin, NT-proBNP, IL-6, and CRP, as well as standard laboratory parameters such as serum creatinine, cystatin C, albuminuria, pH, bicarbonate levels, and HbA1c. All participants with T1DM will undergo cardiological evaluation including clinical examination, electrocardiogram, and transthoracic echocardiography with conventional measurements as well as advanced techniques such as tissue Doppler imaging and speckle-tracking echocardiography. Data collection will be performed at admission and within the first 24-48 hours of hospitalization. The primary objective of the study is to compare biomarker levels and clinical parameters among the three study groups in order to identify early evidence of acute or subclinical organ dysfunction associated with diabetic ketoacidosis in children with newly diagnosed T1DM.

Conditions

• Type 1 Diabetes Mellitus
• Diabetic Ketoacidosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biomarker 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.

Timeline

• Start date: 2025-06-13
• Primary completion: 2029-12-01
• Completion: 2030-03-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Greece