NCT07483879Recruiting
Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed 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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 13 Jun 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- Aristotle University Of Thessaloniki
- Diseases
- Type 1 diabetes
- NCT number
- NCT07483879
What you commit to
- Study type: Observational
- Planned participants: 45
- From 13 Jun 2025 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of diabetes mellitus
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to 16 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hippokration General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.