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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Blood Glucose Levels | Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery. | baseline, 0 hour ICU admission, and 24 hours ICU admission |
| Perioperative Serum Insulin Concentration |
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Inclusion criteria:
Exclusion criteria:
Dropout criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP Dr. Sardjito | Sleman | D.I.Yogyakarta | 55281 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41979300 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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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.
|
| 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. |
|
|
Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes. Higher values indicate higher circulating insulin. |
| baseline, 0 hour ICU admission, and 24 hours ICU admission |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |