Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients
The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited.
This randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This study is a prospective, single-blind, randomized controlled trial of pediatric patients who underwent elective cardiac surgery at Dr. Sardjito General Hospital, Yogyakarta, Indonesia, from April to August 2026. The study sample consisted of pediatric patients aged 2-16 years with an ASA physical status of 2 or 3 who had good tolerance for enteral fluid administration. Patients will be randomly assigned to one of two groups: 1. Intervention Group (Carbohydrate Loading): 3 mL/kg body weight of a maltodextrin-based carbohydrate drink 2 hours before anesthesia; 2. Control Group (Placebo Loading): 3 mL/kg body weight of plain water 2 hours before anesthesia. All patients will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin testing will be collected immediately after induction (baseline), at 0 hours of Intensive Care Unit (ICU) admission, and at 24 hours of ICU admission. The primary outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include blood glucose levels, serum insulin concentration, exogenous insulin dose, and glycemic variability.
All study participants will undergo preoperative assessment, followed by a carbohydrate-loading protocol, and assessment of blood glucose levels, insulin resistance, exogenous insulin administration, and intraoperative and postoperative glycemic variability. Numerical data will be presented as means and standard deviations. Categorical data will be presented as counts and percentages. The Shapiro-Wilk normality test will be applied to all numerical data. Subject characteristics between the two groups will be compared using the Chi-square test for categorical data and the t-test (for normally distributed data) or the Mann-Whitney test (for non-normally distributed data) for numerical data. Pre- and postoperative HOMA-IR values will be compared using a paired t-test if the data are normally distributed, or a two-way ANCOVA (univariate GLM) if they are not. A p-value < 0.05 will be considered statistically significant.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rifdhani Fakhrudin Nur
- Número de teléfono: +6281390051037
- Correo electrónico: rifdhani@mail.ugm.ac.id
Ubicaciones de estudio
-
-
D.I. Yogyakarta
-
Sleman, D.I. Yogyakarta, Indonesia, 55281
- RSUP Dr. Sardjito
-
Contacto:
- Instalasi Diklat RSUP Dr. Sardjito
- Número de teléfono: +628112910226
- Correo electrónico: diklat@sardjitohospital.co.id
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 2-16 years.
- ASA physical status 2 or 3
- Good tolerance of enteral feeding
Exclusion Criteria:
- History of type 1 diabetes mellitus.
- History of thyroid insufficiency treated with thyroid medication.
- History of adrenal insufficiency treated with corticosteroids.
- History of gastroesophageal reflux disease.
- Patients receiving preoperative parenteral nutrition.
- Emergency or urgent cardiac surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Carbohydrate Loading (CL)
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
|
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
The drink is used to lower insulin resistance and improve perioperative recovery.
Otros nombres:
|
|
Comparador de placebos: Placebo Loading (PL)
Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group
|
Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
Periodo de tiempo: Baseline, 0 Hour ICU Admission, 24 hours ICU Admission
|
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is calculated as fasting insulin (µU/mL) × fasting glucose (mmol/L) / 22.5.
Higher values indicate greater insulin resistance.
|
Baseline, 0 Hour ICU Admission, 24 hours ICU Admission
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood Glucose Level
Periodo de tiempo: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
|
Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
|
Baseline, 0 hour ICU Admission, 24 hours ICU Admission
|
|
Serum Insulin Concentration
Periodo de tiempo: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
|
Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes.
Higher values indicate higher circulating insulin.
|
Baseline, 0 hour ICU Admission, 24 hours ICU Admission
|
|
Exogenous Insulin Dose
Periodo de tiempo: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
|
Total daily dose of exogenous insulin (basal and/or bolus) required to achieve glycemic control will be recorded, expressed in units per day (U/day) or units per kilogram body weight per day (U/kg/day).
Change in insulin dose from baseline will be used to reflect changes in insulin requirement/sensitivity.
|
Baseline, 0 hour ICU Admission, 24 hours ICU Admission
|
|
Glycemic Variability
Periodo de tiempo: Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
|
Glycemic variability is defined as the fluctuation of blood glucose levels during the perioperative period, calculated from serial blood glucose measurements.
Variability will be expressed as the standard deviation (SD) and/or coefficient of variation (%CV) of serial glucose values (numeric/continuous scale).
Higher SD/CV values indicate greater glycemic fluctuation during the perioperative period.
|
Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KE/FK/1142/EC/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .