Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

NCT07545538 — Not applicable, Enrolling by invitation, 50 participants, Gadjah Mada University

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

Registry	NCT07545538
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, other
Enrollment	50 (Estimated)
Sponsor	Gadjah Mada University (Other)
Conditions	Insulin Resistance
Interventions	Carbohydrate loading, Water (Placebo) (Other)
Dates	start 2024-01-01, primary completion 2026-04-30 (estimated), completion 2026-06-01 (estimated), first posted 2026-04-22, last updated 2026-05-01
Locations	1 site in Indonesia

-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

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+Detailed description

The tsudy

+Arms and interventions

Arm	Type	Interventions	Description
Carbohydrate loading	Experimental	Other: Carbohydrate loading	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
Placebo	Placebo comparator	Other: Water (Placebo)	Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight

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

+Outcome measures

Primary outcomes

Insulin Resistance [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

+Eligibility

Sex: All, ages: 2 Years to 16 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Sardjito General Hospital	Yogyakarta, Special Region of Yogyakarta	Indonesia