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Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients

24. juli 2026 oppdatert av: Rifdhani Fakhrudin Nur

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

44

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Indonesia
    • D.I. Yogyakarta
      • Sleman, D.I. Yogyakarta, Indonesia, 55281

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Carbohydrate Loading (CL)
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
Kosttilskudd: Carbohydrate
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.
Andre navn:
  • Oralt karbohydratdrikk
  • preoperative carbohydrate loading drink
Placebo komparator: 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
Annen: placebo solution
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.
Andre navn:
  • Vanlig vann
  • Fjern vannplacebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood Glucose Level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rifdhani Fakhrudin Nur

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. august 2026

Primær fullføring (Antatt)

30. oktober 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

24. juli 2026

Først lagt ut (Faktiske)

27. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KE/FK/1142/EC/2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding investigator after publication of study results.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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