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

NCT07212153 | Completed

• 1 other identifier: RIF-RCT2025-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Surgery; Insulin Resistance

Keywords

carbohydrate loading; insulin resistance; cardiac surgery; HOMA-IR

Outcome Measures

Primary Outcomes (1)

• HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)

  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 Outcomes (2)

• Perioperative Blood Glucose Levels

  baseline, 0 hour ICU admission, and 24 hours ICU admission

• Perioperative Serum Insulin Concentration

  baseline, 0 hour ICU admission, and 24 hours ICU admission

Study Arms (2)

Carbohydrate Loading (CL)

EXPERIMENTAL

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)

Placebo Loading (PL)

PLACEBO COMPARATOR

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)

Interventions

Oral Carbohydrate Drink (Maltodextrin) 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.

Also known as: Preoperative carbohydrate loading drink

Carbohydrate Loading (CL)

Placebo (Water) OTHER

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

Also known as: Clear water placebo

Placebo Loading (PL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rifdhani Fakhrudin Nur: lead

Study Sites (1)

RSUP Dr. Sardjito

Sleman, D.I.Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

maltodextrin; Water

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Participants, care providers (surgeons, anesthesiologists, ICU staff), investigators, outcome assessors, data collectors, and analysts were blinded to group allocation. Only the designated study staff who handled randomization and intervention preparation had access to allocation information.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 8, 2025
• Study Start: January 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ID (1)