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

NCT ID: NCT07212153

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-05-30

Brief Summary

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.

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.

Conditions

Cardiac Surgery; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Oral Carbohydrate Drink (Maltodextrin)

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Water)

Intervention Type: OTHER

Participants receive 400 mL of plain water 2 hours before anesthesia induction, following the same protocol and timing as the carbohydrate drink group.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

Preoperative carbohydrate loading drink; Clear water placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rifdhani Fakhrudin Nur

OTHER

Sponsor Role: lead

Responsible Party

Rifdhani Fakhrudin Nur

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

RSUP Dr. Sardjito

Sleman, D.I.Yogyakarta, Indonesia

Countries

Indonesia

Other Identifiers

RIF-RCT2025-001

Identifier Type: -

Identifier Source: org_study_id