Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorAristotle University Of Thessaloniki
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Previous diagnosis of diabetes mellitus
Known chronic kidney disease
Known cardiovascular disease
Acute infection or inflammatory condition unrelated to diabetes
Trial population
Children aged 2-16 years admitted to the pediatric department with newly diagnosed type 1 diabetes mellitus, with or without diabetic ketoacidosis, as well as age-matched healthy children serving as controls.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Biomarker and Echocardiographic Assessment
Diagnostic testBlood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Newly Diagnosed T1DM with DKA1 intervention
Group B: Newly Diagnosed T1DM without DKA1 intervention
Group C: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
Neutrophil Gelatinase-Associated Lipocalin
Measurement of neutrophil gelatinase-associated lipocalin (NGAL, ng/mL) as a biomarker of early renal injury in children with newly diagnosed type 1 diabetes.
Time frame
Within 48 hours of hospitalization2
Kidney Injury Molecule-1
Measurement of kidney injury molecule-1 (KIM-1, ng/mL) as a biomarker of renal injury in children with newly diagnosed type 1 diabetes.
Time frame
Within 48 hours of hospitalization3
High-Sensitivity Troponin
Measurement of high-sensitivity troponin (hs-troponin, ng/L) as a biomarker of myocardial injury in children with newly diagnosed type 1 diabetes.
Time frame
Within 48 hours of hospitalization4
N-terminal pro-B-type Natriuretic Peptide
Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP, pg/mL) as a biomarker of cardiac stress in children with newly diagnosed type 1 diabetes.
Time frame
Within 48 hours of hospitalizationSecondary outcomes
1
Serum Creatinine
Measurement of serum creatinine (mg/dL) in children with newly diagnosed type 1 diabetes.
Time frame
Within 48 hours of hospitalization2
Cystatin C
Measurement of and cystatin C (mg/L) in children with newly diagnosed type 1 diabetes.
Time frame
Within 48 hours of hospitalization3
Left Ventricular Ejection Fraction
Assessment of left ventricular systolic function using left ventricular ejection fraction measured by transthoracic echocardiography.
Time frame
Within 48 hours of hospitalization4
Left Ventricular Fractional Shortening
Evaluation of left ventricular systolic function using fractional shortening measured by transthoracic echocardiography.
Time frame
Within 48 hours of hospitalizationSponsors and contacts
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Source ClinicalTrials.gov