Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Cardiac Surgery Patients

September 30, 2025 updated by: Rifdhani Fakhrudin Nur

The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Patients Undergoing Cardiac Surgery

The goal of this clinical trial is to investigate the effect of preoperative oral carbohydrate on insulin resistance in adult cardiac surgery patients with a cardiopulmonary bypass machine. Insulin resistance is when the body does not respond well to insulin, which can raise blood sugar and slow recovery.

The main question this study aims to answer is:

Does drinking a carbohydrate drink 2 hours before surgery lower insulin resistance compared to drinking only water after on pump cardiac surgery?

Researchers will compare two groups:

One group will drink 400 milliliters of a maltodextrin (carbohydrate) drink (CL group). The other group will drink 400 milliliters of water (PL group).

Participants will:

  1. Be randomly assigned to one of the two groups.
  2. Have blood samples taken to measure insulin and glucose before and after surgery (at hour-0, and hour-24 after ICU admission).
  3. Be monitored in the intensive care unit for 24 hours after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized controlled trial is designed to evaluate whether preoperative oral carbohydrate loading reduces perioperative insulin resistance in adults undergoing elective cardiac surgery at Dr. Sardjito Hospital, Yogyakarta, Indonesia. Fifty participants aged 20-60 years with American Society of Anesthesiologists (ASA) physical status II-III will be randomly assigned to one of two groups:

  1. Intervention group (Carbohydrate Loading, CL): participants will receive 400 milliliters of a maltodextrin-based carbohydrate drink 2 hours before anesthesia.
  2. Control group (Placebo Loading, PL): participants will receive 400 milliliters of plain water 2 hours before anesthesia.

All participants will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin will be taken immediately after induction of anesthesia, upon ICU admission (hour 0), and at hour 24 in the ICU. The main outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include perioperative glucose levels and postoperative insulin requirements.

Randomization is computer-generated, with allocation concealed until assignment. Surgeons, anesthesiologists, ICU staff, outcome assessors, and data analysts will be blinded to group allocation. The sample size of 50 participants (25 per group) was calculated based on prior effect sizes, with 80% power and a two-sided alpha of 0.05.

Data will be analyzed using descriptive statistics and appropriate tests for continuous and categorical variables. Between-group comparisons will use Student's t-test or Mann-Whitney U test as appropriate. Normality will be assessed by Shapiro-Wilk test. Repeated measures will be analyzed with paired tests or ANCOVA models. A p-value <0.05 will be considered statistically significant.

This study is expected to provide new evidence on whether preoperative carbohydrate loading can reduce insulin resistance in the specific context of cardiac surgery, and potentially improve perioperative management and patient recovery.

Study Type

Interventional

Enrollment (Actual)

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
    • D.I.Yogyakarta
      • Sleman, D.I.Yogyakarta, Indonesia, 55281
        • RSUP Dr. Sardjito

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Age 20 to 60 years
  • ASA physical status II or III
  • Good tolerance to enteral fluid administration

Exclusion criteria:

  • History of diabetes mellitus
  • Thyroid insufficiency
  • Adrenal insufficiency
  • Gastroesophageal reflux disease
  • Emergency cardiac surgery

Dropout criteria:

  • Participant withdraws consent
  • Cardiac surgery duration exceeds 4 hours

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbohydrate Loading (CL)
Participants receive 400 mL of a maltodextrin-based carbohydrate drink 2 hours before surgery. The drink contains 50 g of carbohydrate (maltodextrin).
Dietary supplement: Oral Carbohydrate Drink (Maltodextrin)
Participants receive 400 mL of a clear beverage containing 50 g of maltodextrin (carbohydrate) 2 hours before anesthesia induction. The drink is used to lower insulin resistance and improve perioperative recovery.
Other Names:
  • Preoperative carbohydrate loading drink
Placebo Comparator: Placebo Loading (PL)
Participants receive 400 mL of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
Other: Placebo (Water)
Participants receive 400 mL of plain water 2 hours before anesthesia induction, following the same protocol and timing as the carbohydrate drink group.
Other Names:
  • Clear water placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
Time Frame: baseline, 0 hour ICU admission, and 24 hours ICU admission
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is calculated as fasting insulin (µU/mL) × fasting glucose (mmol/L) / 22.5. Higher values indicate greater insulin resistance.
baseline, 0 hour ICU admission, and 24 hours ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Blood Glucose Levels
Time Frame: baseline, 0 hour ICU admission, and 24 hours ICU admission
Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
baseline, 0 hour ICU admission, and 24 hours ICU admission
Perioperative Serum Insulin Concentration
Time Frame: baseline, 0 hour ICU admission, and 24 hours ICU admission
Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes. Higher values indicate higher circulating insulin.
baseline, 0 hour ICU admission, and 24 hours ICU admission

Collaborators and Investigators

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

Sponsor

Rifdhani Fakhrudin Nur

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 (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Estimated)

October 8, 2025

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIF-RCT2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding investigator after publication of study results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

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