Type 1 Diabetes (T1D) Clinical Trials

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Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Greece
Hippokration General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Contact Information
Primary
Athina Stamati
atstamati@gmail.com
+30 6958796612
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2030-03
Participants
Target number of participants: 45
Treatments
Newly Diagnosed T1DM with DKA
Children with newly diagnosed type 1 diabetes mellitus presenting with diabetic ketoacidosis at hospital admission.
Newly Diagnosed T1DM without DKA
Children with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis.
Healthy Controls
Age-matched healthy children without diabetes serving as the control group.
Sponsors
Leads: Aristotle University Of Thessaloniki

This content was sourced from clinicaltrials.gov