Cardiac SurgeryNCT07729280
Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients
A study testing Carbohydrate in people with Cardiac Surgery and Insulin Resistance, run by Rifdhani Fakhrudin Nur at 1 site in Indonesia.
Trial summary
Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Cardiac Surgery, Insulin Resistance, Pediatric Cardiac Surgery
- What is being tested?
- Carbohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Aug 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-16 years.
- ASA physical status 2 or 3
- Good tolerance of enteral feeding
Who cannot join
- History of type 1 diabetes mellitus.
- History of thyroid insufficiency treated with thyroid medication.
- History of adrenal insufficiency treated with corticosteroids.
- History of gastroesophageal reflux disease.
- Patients receiving preoperative parenteral nutrition.
- Emergency or urgent cardiac surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
RSUP Dr. Sardjito
Sleman, D.I. Yogyakarta, 55281
Instalasi Diklat RSUP Dr. Sardjito, +628112910226, diklat@sardjitohospital.co.id
About this study
Official title: The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited.
This randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.
Read the detailed description
This study is a prospective, single-blind, randomized controlled trial of pediatric patients who underwent elective cardiac surgery at Dr. Sardjito General Hospital, Yogyakarta, Indonesia, from April to August 2026. The study sample consisted of pediatric patients aged 2-16 years with an ASA physical status of 2 or 3 who had good tolerance for enteral fluid administration. Patients will be randomly assigned to one of two groups: 1. Intervention Group (Carbohydrate Loading): 3 mL/kg body weight of a maltodextrin-based carbohydrate drink 2 hours before anesthesia; 2. Control Group (Placebo Loading): 3 mL/kg body weight of plain water 2 hours before anesthesia. All patients will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin testing will be collected immediately after induction (baseline), at 0 hours of Intensive Care Unit (ICU) admission, and at 24 hours of ICU admission. The primary outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include blood glucose levels, serum insulin concentration, exogenous insulin dose, and glycemic variability.
All study participants will undergo preoperative assessment, followed by a carbohydrate-loading protocol, and assessment of blood glucose levels, insulin resistance, exogenous insulin administration, and intraoperative and postoperative glycemic variability. Numerical data will be presented as means and standard deviations. Categorical data will be presented as counts and percentages. The Shapiro-Wilk normality test will be applied to all numerical data. Subject characteristics between the two groups will be compared using the Chi-square test for categorical data and the t-test (for normally distributed data) or the Mann-Whitney test (for non-normally distributed data) for numerical data. Pre- and postoperative HOMA-IR values will be compared using a paired t-test if the data are normally distributed, or a two-way ANCOVA (univariate GLM) if they are not. A p-value < 0.05 will be considered statistically significant.
- Being tested
- Carbohydrate, placebo solution
- Keywords
- Cardiac surgery, Carbohydrate loading, Insulin resistance, Glycemic variability
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateDietary supplement
Also called preoperative carbohydrate loading drink, Oral carbohydrate drink
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction. The drink is used to lower insulin resistance and improve perioperative recovery.
placebo solutionOther
Also called Clear water placebo, Plain water
Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Loading (CL) | Experimental | Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction. Receives: Dietary Supplement: Carbohydrate |
| Placebo Loading (PL) | Placebo comparator | Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group Receives: Other: placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 0 Hour ICU Admission, 24 hours ICU Admission
Secondary outcomes (4)
Blood Glucose Level
Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
Measured: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Serum Insulin Concentration
Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes. Higher values indicate higher circulating insulin.
Measured: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Exogenous Insulin Dose
Total daily dose of exogenous insulin (basal and/or bolus) required to achieve glycemic control will be recorded, expressed in units per day (U/day) or units per kilogram body weight per day (U/kg/day). Change in insulin dose from baseline will be used to reflect changes in insulin requirement/sensitivity.
Measured: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Glycemic Variability
Glycemic variability is defined as the fluctuation of blood glucose levels during the perioperative period, calculated from serial blood glucose measurements. Variability will be expressed as the standard deviation (SD) and/or coefficient of variation (%CV) of serial glucose values (numeric/continuous scale). Higher SD/CV values indicate greater glycemic fluctuation during the perioperative period.
Measured: Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rifdhani Fakhrudin Nur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rifdhani Fakhrudin Nur, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729280
- Sponsor's protocol ID
- KE/FK/1142/EC/2026
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding investigator after publication of study results.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07729280
- Acronym / sponsor ID
- KE/FK/1142/EC/2026
- Keywords
- Cardiac surgery, Carbohydrate loading, Insulin resistance, Glycemic variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Rifdhani Fakhrudin NurUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited.
This randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.
Detailed description
This study is a prospective, single-blind, randomized controlled trial of pediatric patients who underwent elective cardiac surgery at Dr. Sardjito General Hospital, Yogyakarta, Indonesia, from April to August 2026. The study sample consisted of pediatric patients aged 2-16 years with an ASA physical status of 2 or 3 who had good tolerance for enteral fluid administration. Patients will be randomly assigned to one of two groups: 1. Intervention Group (Carbohydrate Loading): 3 mL/kg body weight of a maltodextrin-based carbohydrate drink 2 hours before anesthesia; 2. Control Group (Placebo Loading): 3 mL/kg body weight of plain water 2 hours before anesthesia. All patients will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin testing will be collected immediately after induction (baseline), at 0 hours of Intensive Care Unit (ICU) admission, and at 24 hours of ICU admission. The primary outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include blood glucose levels, serum insulin concentration, exogenous insulin dose, and glycemic variability.
All study participants will undergo preoperative assessment, followed by a carbohydrate-loading protocol, and assessment of blood glucose levels, insulin resistance, exogenous insulin administration, and intraoperative and postoperative glycemic variability. Numerical data will be presented as means and standard deviations. Categorical data will be presented as counts and percentages. The Shapiro-Wilk normality test will be applied to all numerical data. Subject characteristics between the two groups will be compared using the Chi-square test for categorical data and the t-test (for normally distributed data) or the Mann-Whitney test (for non-normally distributed data) for numerical data. Pre- and postoperative HOMA-IR values will be compared using a paired t-test if the data are normally distributed, or a two-way ANCOVA (univariate GLM) if they are not. A p-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Loading (CL) | Experimental | Dietary Supplement: CarbohydrateParticipants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction. |
| Placebo Loading (PL) | Placebo comparator | Other: placebo solutionParticipants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 2-16 years.
- ASA physical status 2 or 3
- Good tolerance of enteral feeding
Key exclusion criteria (6 listed)
- History of type 1 diabetes mellitus.
- History of thyroid insufficiency treated with thyroid medication.
- History of adrenal insufficiency treated with corticosteroids.
- History of gastroesophageal reflux disease.
- Patients receiving preoperative parenteral nutrition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbohydrateAlso: preoperative carbohydrate loading drink, Oral carbohydrate drinkParticipants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction. The drink is used to lower insulin resistance and improve perioperative recovery. | Dietary supplement | Carbohydrate Loading (CL) |
| placebo solutionAlso: Clear water placebo, Plain waterParticipants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group. | Other | Placebo Loading (PL) |
Primary outcome
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
Time frame: Baseline, 0 Hour ICU Admission, 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.
4 secondary outcomes
Blood Glucose Level
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Serum Insulin Concentration
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Exogenous Insulin Dose
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Glycemic Variability
Time frame: Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding investigator after publication of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate in people with Cardiac Surgery and Insulin Resistance, run by Rifdhani Fakhrudin Nur at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rifdhani Fakhrudin Nur (+6281390051037, rifdhani@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance) (time frame: Baseline, 0 Hour ICU Admission, 24 hours ICU Admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.