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Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07545538
Enrollment
50
Registered
2026-04-22
Start date
2024-01-01
Completion date
2026-06-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

insulin resistance, HOMA-IR, pediatric surgery

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

Detailed description

The tsudy

Interventions

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

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

Sponsors

Gadjah Mada University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

Only assessor are blinded to the masking. Participants are asked for consent to receive the intervention

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin Resistancemeasured just before incision and 24 hour after surgeryInsulin resistance is measured using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), with the formula of (Insulin concentration x Glucose concentration)/22.5

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026