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Enrolling by Invitation

NCT Number: NCT07545538

Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

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

Enrolling by Invitation

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sardjito General Hospital

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

About this study

The tsudy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Water (Placebo)

Other

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

Primary outcomes

  1. Insulin Resistance

    Time frame: measured just before incision and 24 hour after surgery

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

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

The Effectiveness of Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Patients Undergoing Elective Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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