Actively Recruiting
Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis
Led by Aristotle University Of Thessaloniki · Updated on 2026-03-19
45
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetic ketoacidosis (DKA) is a serious complication in children newly diagnosed with type 1 diabetes mellitus (T1DM) that can cause early damage to vital organs like the kidneys and heart. Detecting organ problems early is important to identify children at higher risk for complications. This observational cross-sectional study compares biomarkers and clinical heart-related measures in children with new T1DM who have DKA, those without DKA, and healthy children to better understand acute organ injury associated with DKA. Participants are divided into three groups: children with newly diagnosed T1DM and DKA, children with newly diagnosed T1DM without DKA, and healthy children without diabetes as controls. Blood and urine samples will be collected at hospital admission to measure biomarkers such as KIM-1, NGAL, high-sensitivity troponin, NT-proBNP, interleukin-6, and C-reactive protein. Children with T1DM will also have heart evaluations including physical exams, electrocardiograms, and detailed echocardiograms using advanced imaging techniques. Data collection occurs during admission and within 24 to 48 hours of hospitalization. During the study, researchers will monitor biomarker levels and heart function to detect early signs of organ injury. Standard lab tests like serum creatinine, cystatin C, and HbA1c will also be measured. The primary outcomes focus on changes in specific biomarkers within 48 hours of hospitalization. This study helps understand how DKA affects organ health shortly after diagnosis. Participation involves hospital visits for sample collection and heart assessments during the initial treatment period, with all evaluations conducted under medical supervision.
CONDITIONS
Brief Title
Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 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
- Age-matched healthy children without diabetes for control group
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 48 hours of hospitalization
Participants undergo blood and urine sample collection and echocardiographic evaluation to assess biomarkers and clinical parameters related to acute organ injury.
1 to 2 visits within 48 hours of hospital admission
Duration - Up to 48 hours following initial evaluation
Participants are observed for changes in clinical and echocardiographic parameters to identify early evidence of acute or subclinical organ dysfunction associated with diabetic ketoacidosis.
Visits as part of hospital stay lasting up to 48 hours
Trial Site Locations
Total: 1 location
1
Hippokration General Hospital of Thessaloniki
Thessaloniki, Central Makedonia, Greece
Actively Recruiting
Research Team
A
Athina Stamati
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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