NCT07483879

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
43mo left

Started Jun 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jun 2025Mar 2030

Study Start

First participant enrolled

June 13, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

March 9, 2026

Last Update Submit

March 17, 2026

Conditions

Type 1 Diabetes MellitusDiabetic Ketoacidosis

Keywords

BiomarkersAcute Kidney InjuryCardiac BiomarkersNGALNT-proBNPhs-TroponinPediatric Type 1 DiabetesMyocardial Strain ImagingKIM-1

Outcome Measures

Primary Outcomes (6)

  • 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.

    Within 48 hours of hospitalization

  • 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.

    Within 48 hours of hospitalization

  • 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.

    Within 48 hours of hospitalization

  • 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.

    Within 48 hours of hospitalization

  • Interleukin-6

    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

    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 Outcomes (11)

  • Serum Creatinine

    Within 48 hours of hospitalization

  • Cystatin C

    Within 48 hours of hospitalization

  • Left Ventricular Ejection Fraction

    Within 48 hours of hospitalization

  • Left Ventricular Fractional Shortening

    Within 48 hours of hospitalization

  • E/e' Ratio

    Within 48 hours of hospitalization

  • +6 more secondary outcomes

Study Arms (3)

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

Newly Diagnosed T1DM without DKA

Children with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis.

Diagnostic Test: Biomarker and Echocardiographic Assessment

Healthy Controls

Age-matched healthy children without diabetes serving as the control group.

Diagnostic Test: Biomarker and Echocardiographic Assessment

Interventions

Biomarker and Echocardiographic AssessmentDIAGNOSTIC_TEST

Blood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes.

Healthy ControlsNewly Diagnosed T1DM with DKANewly Diagnosed T1DM without DKA

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippokration General Hospital of Thessaloniki

Thessaloniki, Central Makedonia, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples collected during hospital admission will be stored for the measurement of biomarkers related to acute organ injury, including KIM-1, NGAL, hs-troponin, NT-proBNP, IL-6, CRP, and cystatin C. Samples may be retained for future analyses related to the objectives of this study.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic KetoacidosisAcute Kidney Injury

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesKetosisAcidosisAcid-Base ImbalanceDiabetes ComplicationsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Athanasios Christoforidis

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Athina Stamati

CONTACT

+30 6958796612atstamati@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics - Pediatric Endocrinology

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 19, 2026

Study Start

June 13, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

GR(1)