ClinicalTrials.gg
Enrolling by invitationNCT07545538Updated May 1, 2026

Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

An interventional study of Carbohydrate loading and Water (Placebo) in Insulin Resistance, sponsored by Gadjah Mada University. Enrolling by invitation at 1 site in Indonesia. Open to participants aged 2 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Gadjah Mada University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 2 years 3 months after the study started (first participant enrolled Jan 2024, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
2 Years to 16 Years
Sex
All
01

Study 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

Read the detailed description

The tsudy

02

Conditions studied

  • Insulin Resistance

Browse trials for

Keywords

  • insulin resistance
  • HOMA-IR
  • pediatric surgery
03

In context

Insulin Resistance

2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Gadjah Mada University is the lead sponsor of 63 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subjects consume 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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)

Interventions

  • OtherCarbohydrate 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

  • OtherWater (Placebo)

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

06

What researchers measure

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

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — The age of participants, glucose level, and insulin level measured will be shared

Supporting information: Study protocol, Statistical analysis plan

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07545538
Lead sponsor
Gadjah Mada University
Responsible party
Yunita Widyastuti (Professor in Pediatric Anesthesia, Gadjah Mada University) — Principal investigator
First posted
Apr 22, 2026
Start date
Jan 1, 2024
Primary completion
Apr 30, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
May 1, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion