Type 1 Diabetes MellitusNCT07483879
Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus and Diabetic Ketoacidosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetic Ketoacidosis
- What is being tested?
- Biomarker and Echocardiographic Assessment
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 13 Jun 2025to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-16 years admitted to the pediatric department with newly diagnosed type 1 diabetes mellitus, with or without diabetic ketoacidosis, as well as age-matched healthy children serving as controls.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Hippokration General Hospital of Thessaloniki
Thessaloniki, Central Makedonia
Athina Stamati, +30 6958796612, atstamati@gmail.com
Athanasios Christoforidis
About this study
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
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.
Read the detailed 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 inflammatory activation.
Recent studies suggest that novel biomarkers may allow early detection of organ dysfunction before conventional clinical indicators become abnormal. Biomarkers such as kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, high-sensitivity troponin (hs-troponin), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) have been proposed as sensitive indicators of kidney and myocardial injury. Inflammatory markers such as interleukin-6 (IL-6) and C-reactive protein (CRP) may also reflect systemic inflammatory activation associated with metabolic decompensation.
The aim of this observational cross-sectional study is to investigate and compare biomarkers of acute organ injury and related 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.
Participants will be categorized into three groups: (1) children with newly diagnosed T1DM presenting with DKA, (2) children with newly diagnosed T1DM without DKA, and (3) healthy children serving as controls. Blood samples will be collected at hospital admission for measurement of biomarkers including KIM-1, NGAL, hs-troponin, NT-proBNP, IL-6, and CRP, as well as standard laboratory parameters such as serum creatinine, cystatin C, albuminuria, pH, bicarbonate levels, and HbA1c.
All participants with T1DM will undergo cardiological evaluation including clinical examination, electrocardiogram, and transthoracic echocardiography with conventional measurements as well as advanced techniques such as tissue Doppler imaging and speckle-tracking echocardiography. Data collection will be performed at admission and within the first 24-48 hours of hospitalization.
The primary objective of the study is to compare biomarker levels and clinical parameters among the three study groups in order to identify early evidence of acute or subclinical organ dysfunction associated with diabetic ketoacidosis in children with newly diagnosed T1DM.
- Conditions
- Type 1 Diabetes Mellitus, Diabetic Ketoacidosis
- Being tested
- Biomarker and Echocardiographic Assessment
- Keywords
- Biomarkers, Acute Kidney Injury, Cardiac Biomarkers, NGAL, NT-proBNP, hs-Troponin, Pediatric Type 1 Diabetes, Myocardial Strain Imaging, KIM-1
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Ketoacidosis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker and Echocardiographic AssessmentDiagnostic test
Blood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed T1DM with DKA | Children with newly diagnosed type 1 diabetes mellitus presenting with diabetic ketoacidosis at hospital admission. Receives: Diagnostic Test: Biomarker and Echocardiographic Assessment | |
| Newly Diagnosed T1DM without DKA | Children with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis. Receives: Diagnostic Test: Biomarker and Echocardiographic Assessment | |
| Healthy Controls | Age-matched healthy children without diabetes serving as the control group. Receives: Diagnostic Test: Biomarker and Echocardiographic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 48 hours of hospitalization
Secondary outcomes (11)
Serum Creatinine
Measurement of serum creatinine (mg/dL) in children with newly diagnosed type 1 diabetes.
Measured: Within 48 hours of hospitalization
Cystatin C
Measurement of and cystatin C (mg/L) in children with newly diagnosed type 1 diabetes.
Measured: Within 48 hours of hospitalization
Left Ventricular Ejection Fraction
Assessment of left ventricular systolic function using left ventricular ejection fraction measured by transthoracic echocardiography.
Measured: Within 48 hours of hospitalization
Left Ventricular Fractional Shortening
Evaluation of left ventricular systolic function using fractional shortening measured by transthoracic echocardiography.
Measured: 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').
Measured: 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.
Measured: 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.
Measured: Within 48 hours of hospitalization
Insulin Autoantibodies (IAA)
Measurement of insulin autoantibodies (IAA) in children with newly diagnosed type 1 diabetes.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 Jun 2025
- Primary completionDec 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Christoforidis, Aristotle University Of Thessaloniki
- Investigators
- Athanasios Christoforidis, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483879
- Sponsor's protocol ID
- AUTH-AC-3
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and data protection regulations and the presence of sensitive clinical information from pediatric participants.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07483879
- Acronym / sponsor ID
- AUTH-AC-3
- Conditions
- Type 1 Diabetes Mellitus, Diabetic Ketoacidosis
- Keywords
- Biomarkers, Acute Kidney Injury, Cardiac Biomarkers, NGAL, NT-proBNP, hs-Troponin, Pediatric Type 1 Diabetes, Myocardial Strain Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 inflammatory activation.
Recent studies suggest that novel biomarkers may allow early detection of organ dysfunction before conventional clinical indicators become abnormal. Biomarkers such as kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), cystatin C, high-sensitivity troponin (hs-troponin), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) have been proposed as sensitive indicators of kidney and myocardial injury. Inflammatory markers such as interleukin-6 (IL-6) and C-reactive protein (CRP) may also reflect systemic inflammatory activation associated with metabolic decompensation.
The aim of this observational cross-sectional study is to investigate and compare biomarkers of acute organ injury and related 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.
Participants will be categorized into three groups: (1) children with newly diagnosed T1DM presenting with DKA, (2) children with newly diagnosed T1DM without DKA, and (3) healthy children serving as controls. Blood samples will be collected at hospital admission for measurement of biomarkers including KIM-1, NGAL, hs-troponin, NT-proBNP, IL-6, and CRP, as well as standard laboratory parameters such as serum creatinine, cystatin C, albuminuria, pH, bicarbonate levels, and HbA1c.
All participants with T1DM will undergo cardiological evaluation including clinical examination, electrocardiogram, and transthoracic echocardiography with conventional measurements as well as advanced techniques such as tissue Doppler imaging and speckle-tracking echocardiography. Data collection will be performed at admission and within the first 24-48 hours of hospitalization.
The primary objective of the study is to compare biomarker levels and clinical parameters among the three study groups in order to identify early evidence of acute or subclinical organ dysfunction associated with diabetic ketoacidosis in children with newly diagnosed T1DM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed T1DM with DKA | – | Diagnostic Test: Biomarker and Echocardiographic AssessmentChildren with newly diagnosed type 1 diabetes mellitus presenting with diabetic ketoacidosis at hospital admission. |
| Newly Diagnosed T1DM without DKA | – | Diagnostic Test: Biomarker and Echocardiographic AssessmentChildren with newly diagnosed type 1 diabetes mellitus without diabetic ketoacidosis. |
| Healthy Controls | – | Diagnostic Test: Biomarker and Echocardiographic AssessmentAge-matched healthy children without diabetes serving as the control group. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-16 years admitted to the pediatric department with newly diagnosed type 1 diabetes mellitus, with or without diabetic ketoacidosis, as well as age-matched healthy children serving as controls.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker and Echocardiographic AssessmentBlood and urine samples and echocardiographic evaluation performed as part of the clinical assessment of children with newly diagnosed type 1 diabetes. | Diagnostic test | Healthy Controls, Newly Diagnosed T1DM with DKA, Newly Diagnosed T1DM without DKA |
Primary outcome
Neutrophil Gelatinase-Associated Lipocalin
Time frame: Within 48 hours of hospitalization
Measurement of neutrophil gelatinase-associated lipocalin (NGAL, ng/mL) as a biomarker of early renal injury in children with newly diagnosed type 1 diabetes.
Kidney Injury Molecule-1
Time frame: Within 48 hours of hospitalization
Measurement of kidney injury molecule-1 (KIM-1, ng/mL) as a biomarker of renal injury in children with newly diagnosed type 1 diabetes.
High-Sensitivity Troponin
Time frame: Within 48 hours of hospitalization
Measurement of high-sensitivity troponin (hs-troponin, ng/L) as a biomarker of myocardial injury in children with newly diagnosed type 1 diabetes.
N-terminal pro-B-type Natriuretic Peptide
Time frame: Within 48 hours of hospitalization
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.
Interleukin-6
Time frame: Within 48 hours of hospitalization
Measurement of interleukin-6 (IL-6, pg/mL) as a biomarker of systemic inflammation in children with newly diagnosed type 1 diabetes.
C-reactive Protein
Time frame: Within 48 hours of hospitalization
Measurement of C-reactive protein (CRP, mg/L) as a biomarker of systemic inflammation in children with newly diagnosed type 1 diabetes.
11 secondary outcomes
Serum Creatinine
Time frame: Within 48 hours of hospitalization
Cystatin C
Time frame: Within 48 hours of hospitalization
Left Ventricular Ejection Fraction
Time frame: Within 48 hours of hospitalization
Left Ventricular Fractional Shortening
Time frame: Within 48 hours of hospitalization
E/e' Ratio
Time frame: Within 48 hours of hospitalization
Left Ventricular Global Longitudinal Strain
Time frame: Within 48 hours of hospitalization
Glutamic Acid Decarboxylase Antibodies (GAD65)
Time frame: Within 48 hours of hospitalization
Insulin Autoantibodies (IAA)
Time frame: Within 48 hours of hospitalization
Islet Antigen-2 Antibodies (IA-2)
Time frame: Within 48 hours of hospitalization
Zinc Transporter 8 Antibodies (ZnT8)
Time frame: Within 48 hours of hospitalization
Severity of Diabetic Ketoacidosis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and data protection regulations and the presence of sensitive clinical information from pediatric participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Athanasios Christoforidis principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Diabetic Ketoacidosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athina Stamati (+30 6958796612, atstamati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil Gelatinase-Associated Lipocalin (time frame: Within 48 hours of hospitalization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.