Markers of early kidney and heart injury in children newly diagnosed with type 1 diabetes
Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis
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 |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki, Central Makedonia) |
| Trial ID | NCT07483879 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Thessaloniki, Central Makedonia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.