The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Adult Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 60 years
- •ASA physical status II or III
- •Good tolerance to enteral fluid administration
排除标准
- •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
研究组 & 干预措施
Carbohydrate Loading (CL)
Participants receive 400 mL of a maltodextrin-based carbohydrate drink 2 hours before surgery. The drink contains 50 g of carbohydrate (maltodextrin).
干预措施: Oral Carbohydrate Drink (Maltodextrin) (Dietary Supplement)
Placebo Loading (PL)
Participants receive 400 mL of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
干预措施: Placebo (Water) (Other)
结局指标
主要结局
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
时间窗: 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.
次要结局
- 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)
研究者
Rifdhani Fakhrudin Nur
Principal Investigator
Gadjah Mada University