NCT07483879 Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes
| NCT ID | NCT07483879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aristotle University Of Thessaloniki |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2025-06-13 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Athanasios Christoforidis
PRINCIPAL INVESTIGATOR
Aristotle University Of Thessaloniki
Frequently Asked Questions
Who can join the NCT07483879 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07483879 currently recruiting?
Yes, NCT07483879 is actively recruiting participants. Contact the research team at atstamati@gmail.com for enrollment information.
Where is the NCT07483879 trial being conducted?
This trial is being conducted at Thessaloniki, Greece.
Who is sponsoring the NCT07483879 clinical trial?
NCT07483879 is sponsored by Aristotle University Of Thessaloniki. The principal investigator is Athanasios Christoforidis at Aristotle University Of Thessaloniki. The trial plans to enroll 45 participants.
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