Markers of early kidney and heart injury in children newly diagnosed with type 1 diabetes
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
Run by Aristotle University Of Thessaloniki · NCT07483879 · Data updated 2026-11-12
This study will test whether blood markers and heart ultrasound can find early kidney or heart injury in children aged 2–16 who are newly diagnosed with type 1 diabetes, comparing those with diabetic ketoacidosis, those without, and healthy children.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 16 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki, Central Makedonia) |
| Status | Recruiting |
| Started | June 13, 2025 |
| Main results expected | December 2029 |
| Study ends | March 2030 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07483879 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2–16 who are newly diagnosed with type 1 diabetes and admitted for initial evaluation, including both those with and without diabetic ketoacidosis, plus age-matched healthy children as controls.
✕Probably not a fit
Children with prior chronic kidney disease, known cardiovascular disease, acute non-diabetes infections, or on medications that affect renal or cardiac biomarkers are unlikely to receive useful information from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cross-sectional study will measure blood biomarkers (KIM-1, NGAL, cystatin C, high-sensitivity troponin, NT-proBNP, IL-6, CRP) and perform echocardiography during hospital admission and within the first 24–48 hours. Participants are grouped as newly diagnosed T1D with DKA, newly diagnosed T1D without DKA, and age-matched healthy controls. Clinical, laboratory, and echocardiographic parameters will be compared across groups to identify signals of subclinical kidney and cardiac injury. Findings will be used to inform whether these markers could guide earlier monitoring or interventions in pediatric DKA.
Why it matters
Potential benefit: If successful, this could allow earlier detection of kidney or heart injury in children with new-onset type 1 diabetes so clinicians can monitor and treat at-risk children sooner to reduce complications.
How similar studies have gone: Related biomarker work in adults and small pediatric series has shown promise for early organ injury detection, but robust pediatric data specifically in DKA are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hippokration General Hospital of Thessaloniki
Thessaloniki, Central Makedonia, Greece Recruiting
Study contacts
- Principal investigator: Athanasios Christoforidis — Aristotle University Of Thessaloniki
- Study coordinator: Athina Stamati
- Email: atstamati@gmail.com
- Phone: +30 6958796612
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.