NCT07729280

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

August 25, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 21, 2026

Last Update Submit

July 24, 2026

Conditions

Cardiac SurgeryInsulin ResistancePediatric Cardiac Surgery

Keywords

Cardiac surgeryCarbohydrate loadingInsulin resistanceGlycemic variability

Outcome Measures

Primary Outcomes (1)

  • HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)

    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

Secondary Outcomes (4)

  • Blood Glucose Level

    Baseline, 0 hour ICU Admission, 24 hours ICU Admission

  • Serum Insulin Concentration

    Baseline, 0 hour ICU Admission, 24 hours ICU Admission

  • Exogenous Insulin Dose

    Baseline, 0 hour ICU Admission, 24 hours ICU Admission

  • Glycemic Variability

    Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission

Study Arms (2)

Carbohydrate Loading (CL)

EXPERIMENTAL

Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.

Dietary Supplement: Carbohydrate

Placebo Loading (PL)

PLACEBO COMPARATOR

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

Other: placebo solution

Interventions

CarbohydrateDIETARY_SUPPLEMENT

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.

Also known as: preoperative carbohydrate loading drink, Oral carbohydrate drink
Carbohydrate Loading (CL)
placebo solutionOTHER

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.

Also known as: Clear water placebo, Plain water
Placebo Loading (PL)

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-16 years.
  • ASA physical status 2 or 3
  • Good tolerance of enteral feeding

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP Dr. Sardjito

Sleman, D.I. Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Rifdhani Fakhrudin Nur

CONTACT

+6281390051037rifdhani@mail.ugm.ac.id

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 27, 2026

Study Start (Estimated)

August 25, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

ID(1)