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

March 17, 2026 updated by: Athanasios Christoforidis, Aristotle University Of Thessaloniki

Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Central Makedonia
      • Thessaloniki, Central Makedonia, Greece
        • Recruiting
        • Hippokration General Hospital of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Athanasios Christoforidis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly Diagnosed T1DM with DKA
Children with newly diagnosed type 1 diabetes mellitus presenting with diabetic ketoacidosis at hospital admission.
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.
Newly Diagnosed T1DM without DKA
Children with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis.
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.
Healthy Controls
Age-matched healthy children without diabetes serving as the control group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil Gelatinase-Associated Lipocalin
Time Frame: Within 48 hours of hospitalization
Measurement of neutrophil gelatinase-associated lipocalin (NGAL, ng/mL) as a biomarker of early renal injury in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Kidney Injury Molecule-1
Time Frame: Within 48 hours of hospitalization
Measurement of kidney injury molecule-1 (KIM-1, ng/mL) as a biomarker of renal injury in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
High-Sensitivity Troponin
Time Frame: Within 48 hours of hospitalization
Measurement of high-sensitivity troponin (hs-troponin, ng/L) as a biomarker of myocardial injury in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
N-terminal pro-B-type Natriuretic Peptide
Time Frame: Within 48 hours of hospitalization
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.
Within 48 hours of hospitalization
Interleukin-6
Time Frame: Within 48 hours of hospitalization
Measurement of interleukin-6 (IL-6, pg/mL) as a biomarker of systemic inflammation in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
C-reactive Protein
Time Frame: Within 48 hours of hospitalization
Measurement of C-reactive protein (CRP, mg/L) as a biomarker of systemic inflammation in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Creatinine
Time Frame: Within 48 hours of hospitalization
Measurement of serum creatinine (mg/dL) in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Cystatin C
Time Frame: Within 48 hours of hospitalization
Measurement of and cystatin C (mg/L) in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Left Ventricular Ejection Fraction
Time Frame: Within 48 hours of hospitalization
Assessment of left ventricular systolic function using left ventricular ejection fraction measured by transthoracic echocardiography.
Within 48 hours of hospitalization
Left Ventricular Fractional Shortening
Time Frame: Within 48 hours of hospitalization
Evaluation of left ventricular systolic function using fractional shortening measured by transthoracic echocardiography.
Within 48 hours of hospitalization
E/e' Ratio
Time Frame: Within 48 hours of hospitalization
Assessment of left ventricular diastolic function using the ratio of transmitral early filling velocity (E) to tissue Doppler early diastolic velocity (e').
Within 48 hours of hospitalization
Left Ventricular Global Longitudinal Strain
Time Frame: Within 48 hours of hospitalization
Assessment of subclinical left ventricular systolic function using global longitudinal strain derived from speckle-tracking echocardiography.
Within 48 hours of hospitalization
Glutamic Acid Decarboxylase Antibodies (GAD65)
Time Frame: Within 48 hours of hospitalization
Measurement of glutamic acid decarboxylase antibodies (GAD65) in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Insulin Autoantibodies (IAA)
Time Frame: Within 48 hours of hospitalization
Measurement of insulin autoantibodies (IAA) in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Islet Antigen-2 Antibodies (IA-2)
Time Frame: Within 48 hours of hospitalization
Measurement of islet antigen-2 antibodies (IA-2) in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Zinc Transporter 8 Antibodies (ZnT8)
Time Frame: Within 48 hours of hospitalization
Measurement of zinc transporter 8 antibodies (ZnT8) in children with newly diagnosed type 1 diabetes.
Within 48 hours of hospitalization
Severity of Diabetic Ketoacidosis
Time Frame: Baseline
Classification of diabetic ketoacidosis severity at hospital admission based on venous blood pH and serum bicarbonate levels according to international pediatric guidelines. Diabetic ketoacidosis will be categorized as mild (pH <7.30, bicarbonate <15 mmol/L), moderate (pH <7.20, bicarbonate <10 mmol/L), or severe (pH <7.10, bicarbonate <5 mmol/L).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Athanasios Christoforidis, Aristotle University of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTH-AC-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and data protection regulations and the presence of sensitive clinical information from pediatric participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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