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Clinical Trial NCT07483879 for Type 1 Diabetes Mellitus, Diabetic Ketoacidosis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes 45 Biomarker-Driven Pediatric Observational
Clinical Trial NCT07483879 is an observational study for Type 1 Diabetes Mellitus, Diabetic Ketoacidosis that is recruiting. It started on 13 June 2025 with plans to enroll 45 participants. Led by Aristotle University Of Thessaloniki, it is expected to complete by 1 March 2030. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
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 inju...
Show MoreDetailed Description
Diabetic ketoacidosis (DKA) is a common and potentially life-threatening metabolic complication in children with newly diagnosed type 1 diabetes mellitus (T1DM). In addition to the acute metabolic disturbances, DKA may lead to early or subclinical injury of vital organs, particularly the kidneys and the cardiovascular system, due to dehydration, hypovolemia, metabolic acidosis, electrolyte disturbances, and inflammat...Show More
Official Title
Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis
Conditions
Type 1 Diabetes MellitusDiabetic KetoacidosisOther Study IDs
- AUTH-AC-3
NCT ID Number
Start Date (Actual)
2025-06-13
Last Update Posted
2026-03-19
Completion Date (Estimated)
2030-03
Enrollment (Estimated)
45
Study Type
Observational
Status
Recruiting
Keywords
Biomarkers
Acute Kidney Injury
Cardiac Biomarkers
NGAL
NT-proBNP
hs-Troponin
Pediatric Type 1 Diabetes
Myocardial Strain Imaging
KIM-1
Acute Kidney Injury
Cardiac Biomarkers
NGAL
NT-proBNP
hs-Troponin
Pediatric Type 1 Diabetes
Myocardial Strain Imaging
KIM-1
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Newly Diagnosed T1DM with DKA Children with newly diagnosed type 1 diabetes mellitus presenting with diabetic ketoacidosis at hospital admission. | Biomarker and Echocardiographic Assessment Blood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes. |
Newly Diagnosed T1DM without DKA Children with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis. | Biomarker and Echocardiographic Assessment Blood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes. |
Healthy Controls Age-matched healthy children without diabetes serving as the control group. | Biomarker and Echocardiographic Assessment Blood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Neutrophil Gelatinase-Associated Lipocalin | Measurement of neutrophil gelatinase-associated lipocalin (NGAL, ng/mL) as a biomarker of early renal injury in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Kidney Injury Molecule-1 | Measurement of kidney injury molecule-1 (KIM-1, ng/mL) as a biomarker of renal injury in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
High-Sensitivity Troponin | Measurement of high-sensitivity troponin (hs-troponin, ng/L) as a biomarker of myocardial injury in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
N-terminal pro-B-type Natriuretic Peptide | Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP, pg/mL) as a biomarker of cardiac stress in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Interleukin-6 | Measurement of interleukin-6 (IL-6, pg/mL) as a biomarker of systemic inflammation in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
C-reactive Protein | Measurement of C-reactive protein (CRP, mg/L) as a biomarker of systemic inflammation in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Serum Creatinine | Measurement of serum creatinine (mg/dL) in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Cystatin C | Measurement of and cystatin C (mg/L) in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Left Ventricular Ejection Fraction | Assessment of left ventricular systolic function using left ventricular ejection fraction measured by transthoracic echocardiography. | Within 48 hours of hospitalization |
Left Ventricular Fractional Shortening | Evaluation of left ventricular systolic function using fractional shortening measured by transthoracic echocardiography. | Within 48 hours of hospitalization |
E/e' Ratio | Assessment of left ventricular diastolic function using the ratio of transmitral early filling velocity (E) to tissue Doppler early diastolic velocity (e'). | Within 48 hours of hospitalization |
Left Ventricular Global Longitudinal Strain | Assessment of subclinical left ventricular systolic function using global longitudinal strain derived from speckle-tracking echocardiography. | Within 48 hours of hospitalization |
Glutamic Acid Decarboxylase Antibodies (GAD65) | Measurement of glutamic acid decarboxylase antibodies (GAD65) in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Insulin Autoantibodies (IAA) | Measurement of insulin autoantibodies (IAA) in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Islet Antigen-2 Antibodies (IA-2) | Measurement of islet antigen-2 antibodies (IA-2) in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Zinc Transporter 8 Antibodies (ZnT8) | Measurement of zinc transporter 8 antibodies (ZnT8) in children with newly diagnosed type 1 diabetes. | Within 48 hours of hospitalization |
Severity of Diabetic Ketoacidosis | Classification of diabetic ketoacidosis severity at hospital admission based on venous blood pH and serum bicarbonate levels according to international pediatric guidelines. Diabetic ketoacidosis will be categorized as mild (pH \<7.30, bicarbonate \<15 mmol/L), moderate (pH \<7.20, bicarbonate \<10 mmol/L), or severe (pH \<7.10, bicarbonate \<5 mmol/L). | Baseline |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
2 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
Aristotle University Of ThessalonikiStudy Responsible Party
Athanasios Christoforidis, Principal Investigator, Professor of Pediatrics - Pediatric Endocrinology, Aristotle University Of Thessaloniki
Study Central Contact
Contact: Athina Stamati, +30 6958796612, [email protected]
1 Study Locations in 1 Countries
Central Makedonia
Hippokration General Hospital of Thessaloniki, Thessaloniki, Central Makedonia, Greece
Athina Stamati, Contact, +30 6958796612, [email protected]
Athanasios Christoforidis, Principal Investigator
Recruiting