Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomarker and Echocardiographic Assessment.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus, Diabetic Ketoacidosis. Basic parameters: 2 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis
Overview
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.
Interventions
- 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.
Primary outcome measures
- Neutrophil Gelatinase-Associated Lipocalin [Time frame: Within 48 hours of hospitalization]
- Kidney Injury Molecule-1 [Time frame: Within 48 hours of hospitalization]
- High-Sensitivity Troponin [Time frame: Within 48 hours of hospitalization]
- N-terminal pro-B-type Natriuretic Peptide [Time frame: Within 48 hours of hospitalization]
- Interleukin-6 [Time frame: Within 48 hours of hospitalization]
- C-reactive Protein [Time frame: Within 48 hours of hospitalization]
Secondary outcome measures (11)
- Serum Creatinine [Time frame: Within 48 hours of hospitalization]
- Cystatin C [Time frame: Within 48 hours of hospitalization]
- Left Ventricular Ejection Fraction [Time frame: Within 48 hours of hospitalization]
- Left Ventricular Fractional Shortening [Time frame: Within 48 hours of hospitalization]
- E/e' Ratio [Time frame: Within 48 hours of hospitalization]
- Left Ventricular Global Longitudinal Strain [Time frame: Within 48 hours of hospitalization]
- Glutamic Acid Decarboxylase Antibodies (GAD65) [Time frame: Within 48 hours of hospitalization]
- Insulin Autoantibodies (IAA) [Time frame: Within 48 hours of hospitalization]
- Islet Antigen-2 Antibodies (IA-2) [Time frame: Within 48 hours of hospitalization]
- Zinc Transporter 8 Antibodies (ZnT8) [Time frame: Within 48 hours of hospitalization]
- Severity of Diabetic Ketoacidosis [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Greece · 1 center
- Hippokration General Hospital of Thessaloniki — Thessaloniki
Identifiers
NCT: NCT07483879 · AUTH-AC-3