Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

April 27, 2026 updated by: Yunita Widyastuti, Gadjah Mada University

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The tsudy

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Special Region of Yogyakarta
      • Yogyakarta, Special Region of Yogyakarta, Indonesia, 55281
        • Sardjito General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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 Comparator: Placebo
Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight
Other: Water (Placebo)
Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measured just before incision and 24 hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE/FK/0951/EC/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The age of participants, glucose level, and insulin level measured will be shared

IPD Sharing Time Frame

Data will be available after the completion of the study

IPD Sharing Access Criteria

Everybody will be able to access the data by personally emailing the study coordinator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Resistance

Clinical Trials on Carbohydrate loading

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe