Cardiac SurgeryNCT07212153
Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Cardiac Surgery Patients
A study testing Oral Carbohydrate Drink (Maltodextrin) in people with Cardiac Surgery and Insulin Resistance, run by Rifdhani Fakhrudin Nur at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Insulin Resistance
- What is being tested?
- Oral Carbohydrate Drink (Maltodextrin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 60 years
- ASA physical status II or III
- Good tolerance to enteral fluid administration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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:
- Be randomly assigned to one of the two groups.
- Have blood samples taken to measure insulin and glucose before and after surgery (at hour-0, and hour-24 after ICU admission).
- Be monitored in the intensive care unit for 24 hours after surgery.
Read the 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:
- Intervention group (Carbohydrate Loading, CL): participants will receive 400 milliliters of a maltodextrin-based carbohydrate drink 2 hours before anesthesia.
- 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
- Being tested
- Oral Carbohydrate Drink (Maltodextrin), Placebo (Water)
- Keywords
- carbohydrate loading, insulin resistance, cardiac surgery, HOMA-IR
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Carbohydrate Drink (Maltodextrin)Dietary supplement
Also called Preoperative carbohydrate loading drink
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 (Water)Other
Also called Clear water placebo
Participants receive 400 mL of plain water 2 hours before anesthesia induction, following the same protocol and timing as the carbohydrate drink group.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Placebo (Water) |
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, and 24 hours ICU admission
Secondary outcomes (2)
Perioperative Blood Glucose Levels
Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
Measured: baseline, 0 hour ICU admission, and 24 hours ICU admission
Perioperative 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, and 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 posted8 Oct 2025
- Study start1 Jan 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
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
- NCT07212153
- Sponsor's protocol ID
- RIF-RCT2025-001
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 8 Oct 2025
- 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.
Publications
Nur RF, Synthana MR, Kurnia Y, Rudiarto KM, Alicia RJ, Kurniawaty J, Pratomo BY, Deviatika FE. The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Patients Undergoing On-Pump Cardiac Surgery: A Randomized Controlled Trial. Ann Card Anaesth. 2026 Apr 1;29(2):228-236. doi: 10.4103/aca.aca_313_25. Epub 2026 Apr 15.
PubMed 41979300
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. 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 Adult Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07212153
- Acronym / sponsor ID
- RIF-RCT2025-001
- Conditions
- Cardiac Surgery, Insulin Resistance
- Keywords
- carbohydrate loading, insulin resistance, cardiac surgery, HOMA-IR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rifdhani Fakhrudin NurUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Oct 2025 (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.
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:
- Be randomly assigned to one of the two groups.
- Have blood samples taken to measure insulin and glucose before and after surgery (at hour-0, and hour-24 after ICU admission).
- 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:
- Intervention group (Carbohydrate Loading, CL): participants will receive 400 milliliters of a maltodextrin-based carbohydrate drink 2 hours before anesthesia.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Loading (CL) | Experimental | Dietary Supplement: Oral Carbohydrate Drink (Maltodextrin)Participants receive 400 mL of a maltodextrin-based carbohydrate drink 2 hours before surgery. The drink contains 50 g of carbohydrate (maltodextrin). |
| Placebo Loading (PL) | Placebo comparator | Other: Placebo (Water)Participants receive 400 mL of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20 to 60 years
- ASA physical status II or III
- Good tolerance to enteral fluid administration
Key exclusion criteria (8 listed)
- History of diabetes mellitus
- Thyroid insufficiency
- Adrenal insufficiency
- Gastroesophageal reflux disease
- Emergency cardiac surgery
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 |
|---|---|---|
| Oral Carbohydrate Drink (Maltodextrin)Also: Preoperative carbohydrate loading drinkParticipants 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. | Dietary supplement | Carbohydrate Loading (CL) |
| Placebo (Water)Also: Clear water placeboParticipants receive 400 mL of plain water 2 hours before anesthesia induction, following the same protocol and timing as the carbohydrate drink group. | Other | Placebo Loading (PL) |
Primary outcome
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.
2 secondary outcomes
Perioperative Blood Glucose Levels
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Derived from this study: PubMed 41979300Nur RF, Synthana MR, Kurnia Y, Rudiarto KM, Alicia RJ, Kurniawaty J, Pratomo BY, Deviatika FE. The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Patients Undergoing On-Pump Cardiac Surgery: A Randomized Controlled Trial. Ann Card Anaesth. 2026 Apr 1;29(2):228-236. doi: 10.4103/aca.aca_313_25. Epub 2026 Apr 15.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Carbohydrate Drink (Maltodextrin) 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 8 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: finished, as of the sponsor's last update on 8 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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, and 24 hours ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07212153, which also lists 1 linked publication.
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 8 Oct 2025.