Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

NCT07545538 | Enrolling By Invitation DMC

• 1 other identifier: KE/FK/0951/EC/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery

Conditions

Insulin Resistance

Keywords

insulin resistance; HOMA-IR; pediatric surgery

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance

  Insulin resistance is measured using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), with the formula of (Insulin concentration x Glucose concentration)/22.5

  measured just before incision and 24 hour after surgery

Study Arms (2)

Carbohydrate loading

EXPERIMENTAL

Subjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight

Other: Carbohydrate loading

Placebo

PLACEBO COMPARATOR

Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight

Other: Water (Placebo)

Interventions

Carbohydrate loading OTHER

Subjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight

Carbohydrate loading

Water (Placebo) OTHER

Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight

Placebo

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA Physical Status I and II
• Able to tolerate enteral feeding
• Subjects are undergoing surgery with general anesthesia

You may not qualify if:

• Subjects consume corticosteroids and insulin
• Subjects have endocrine disorder, gastroesophageal reflux disease and psychiatric disorder
• Subjects are treated with preoperative parenteral nutrition
• The surgical procedure is longer than 4 hours
• Drop out Criteria:
• \- Intraoperative surgical emergency e.g. massive bleeding

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Sardjito General Hospital

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Diet, Carbohydrate Loading; Water

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only assessor are blinded to the masking. Participants are asked for consent to receive the intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Pediatric Anesthesia

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: January 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after the completion of the study
• Access Criteria: Everybody will be able to access the data by personally emailing the study coordinator

Locations

ID (1)