Carbohydrate Loading on Insulin Resistance in Open Heart Surgery

March 28, 2025 updated by: Jefferson K Hidayat, Indonesia University

The Effect of Preoperative Oral Carbohydrate Solution Administration of Insulin Resistance in Patients Undergoing Elective Open-Heart Surgery

This study is a single-blind randomized clinical trial involving 40 adult patients undergoing elective open-heart surgery. The sample was allocated into two groups: 20 subjects in the oral carbohydrate fluid group and 20 subjects in the water group consumed 2 hours before surgery. Insulin resistance was measured by blood glucose levels, HOMA-IR index, and insulin tolerance tests. Postoperative outcomes were assessed by ICU stay duration, ventilator use, and hospital stay duration. Patient comfort factors were measured by hunger, thirst, nausea, and comfort levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In general, preoperative fasting is mandatory for any kind of operations. This is intended to reduce the risk of aspiration during anesthesia procedure. According to recommendation from American Society of Anesthesiologist (ASA), fasting time limit is 8 hours for high calories food, 6 hours for moderate calories food, 4 hours for breastmilk, and 2 hours for clear fluid. Until today, many studies have shown that conventional fasting causes metabolic burden. Lengthy fasting period induces body's stress response, seen in increase in catabolic reaction, elevated contra insulin hormones such as glucocorticoid and catecholamine. In addition to that, surgical stimulus heightens this metabolic reaction which leads to insulin resistance. Insulin resistance causes hyperglycemia, which have a negative impact postoperatively. Several postoperative outcomes have been linked to insulin resistance, such as longer duration of ventilator and hospital stay, as well as the likelihood of postoperative infection. Cardio thorax surgery, as many other major surgeries pose a significant risk of metabolic derangement. Hyperglycemia is known to cause oxidative stress. As the risk of postoperative increases, the mortality and morbidity also increase. In the era of enhanced recovery after surgery, carbohydrate loading is given 2 hours before operation in attempt to improve outcome. Giving 50-250 grams of carbohydrate is expected to suppress catabolic process that usually occurs due to prolonged fasting. This strategy has been implemented in non cardiac surgery, which has shown benefit postoperatively. However, until today there are still limited studies regarding the use of carbohydrate loading on open heart surgeries. The investigators intend to evaluate the benefit of this practice on insulin resistance.

This study was a single-blind randomized clinical trial. The study took place in heart center of Ciptomangunkusumo (RSCM) Hospital and Jakarta Hear Center (JHC) Hospital, for 10 months starting from January 2023 to October 2023. Forty subjects were recruited following the approved ethical clearance by Ethics Committee, Universitas Indonesia. The investigators had a consecutive sampling with inclusion criteria of adult patients aged 18-65 years old who undergo open heart elective surgery and give their consent. The exclusion criteria are those with diabetes mellitus, gastroesophageal reflux, digestive malignancy, dementia, mental disturbances, as well as ASA classification of 4 or more. The drop out criteria applied were those who passed away during operation, experienced hypoglycemia with blood glucose < 70 mg/dl, withdrew from the research, and were not able to finish the data sampling.

Study Type

Interventional

Enrollment (Actual)

40

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
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 1043
        • Rumah Sakit Cipto Mangunkusumo

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:

  • Subjects age 18-65 years old undergoing elective open heart surgery
  • Subjects giving informed consent

Exclusion Criteria:

  • Subjects with diabetes mellitus
  • Subjects with gastroesophageal reflux
  • Subjects with digestive malignancy
  • Subjects with dementia
  • Subjects with mental health
  • Subjects with ASA 4 or more

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Mineral water
Patient is given mineral water 2 hours before operation
Experimental: Glucose Drink
Patient is given glucose water 2 hours before operation
Dietary supplement: Glucose drink
Intervention group will receive maltodextrin glucose drinks 2 hours prior to the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance difference between two groups
Time Frame: Within 30 minutes before and 30 minutes after operation
Insulin resistance seen in the level of blood glucose (mg/dL)
Within 30 minutes before and 30 minutes after operation
Insulin resistance difference between two groups
Time Frame: Within 30 minutes before and 30 minutes after operation
Insulin resistance seen in the level HOMA-IR (unitless)
Within 30 minutes before and 30 minutes after operation
Insulin resistance difference between two groups
Time Frame: Within 30 minutes before and 30 minutes after operation
Insulin resistance seen in the level insulin sensitivity test (%/minute)
Within 30 minutes before and 30 minutes after operation
Operation outcome difference between two groups
Time Frame: From completion of operation to ICU discharge or death, usually under 28 days
Operation outcome in form of length of stay in the ICU (days)
From completion of operation to ICU discharge or death, usually under 28 days
Operation outcome difference between two groups
Time Frame: From completion of operation to hospital discharge or death, usually under 28 days
Operation outcome in form of length of stay in the hospital (days)
From completion of operation to hospital discharge or death, usually under 28 days
Operation outcome difference between two groups
Time Frame: From completion of operation to cessation of ventilator use or death, usually under 28 days
Operation outcome consists of duration of ventilator use (days)
From completion of operation to cessation of ventilator use or death, usually under 28 days
Subjective well being difference between two groups
Time Frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of hunger (Yes or No)
Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being difference between two groups
Time Frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of thrist (Yes or No)
Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being difference between two groups
Time Frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of nausea (Yes or No)
Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being difference between two groups
Time Frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of comfort (Yes or No)
Preoperatively in the preparation room, usually around 1 hour before operation

Collaborators and Investigators

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

Sponsor

Indonesia University

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, 2023

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

January 5, 2024

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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