Studying Biomarkers and Heart and Kidney Health in Children Aged 2 to 16 With Newly Diagnosed Type 1 Diabetes, With and Without Diabetic Ketoacidosis

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.

Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes