Effects of Preoperative Oral Carbohydrate Loading on Postoperative Insulin Resistance and Glycemic Stability in Patients With Type 2 Diabetes Undergoing Elective Gastrointestinal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- Postoperative Day 1 Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
研究概览
简要总结
This study is a single-center randomized controlled trial in adults with type 2 diabetes who are scheduled for elective gastrointestinal surgery. The study aims to find out whether drinking a carbohydrate-containing clear liquid before surgery can reduce early postoperative insulin resistance and improve blood glucose stability without increasing the risk of high or low blood glucose.
Participants will be randomly assigned in a 1:1:1 ratio to one of three groups. The first group will receive standard enhanced recovery after surgery (ERAS) fasting and clear-fluid management without a carbohydrate-containing drink. The second group will drink 400 mL of a 12.5% maltodextrin carbohydrate solution, providing about 50 g of carbohydrate, approximately 2 hours before anesthesia. The third group will receive 500 mL of 10% glucose solution intravenously over approximately 2 hours before anesthesia. The intravenous glucose group is included mainly to help explore whether the route of carbohydrate administration affects the metabolic response.
All participants will receive standard perioperative care. Blood glucose will be monitored during the perioperative period, including continuous glucose monitoring when available, with point-of-care blood glucose testing used to confirm clinically important high or low glucose readings and to guide treatment when necessary.
The primary outcome is insulin resistance on the first day after surgery, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which is calculated from fasting blood glucose and fasting insulin concentrations. Secondary outcomes include perioperative glucose levels and glucose variability, time spent within, above, and below the target glucose range, insulin and C-peptide levels, postoperative nausea and vomiting, patient comfort, postoperative recovery, hospital stay, postoperative complications, and safety events such as hypoglycemia, severe hyperglycemia, reflux, or aspiration.
The main comparison of interest is between the oral carbohydrate group and the standard ERAS group. The intravenous glucose group will be analyzed mainly as a mechanistic exploratory group.
详细描述
Enhanced recovery after surgery (ERAS) programs have progressively shifted perioperative fasting practice away from prolonged fasting toward shorter fasting intervals and the selective use of clear fluids before anesthesia. Preoperative oral carbohydrate loading has been proposed as a metabolic conditioning strategy that may reduce the catabolic effects of fasting, stimulate endogenous insulin secretion, suppress lipolysis, and attenuate the postoperative decline in insulin sensitivity. However, most supporting evidence has been generated in patients without diabetes.
Patients with type 2 diabetes mellitus have baseline insulin resistance, variable pancreatic beta-cell reserve, and altered responses to carbohydrate intake. Surgical stress, anesthesia, pain, and inflammatory responses may further increase hepatic glucose production and reduce peripheral glucose utilization, resulting in postoperative hyperglycemia and worsening insulin resistance. At the same time, prolonged fasting and perioperative changes in glucose-lowering therapy may increase the risks of hypoglycemia and glycemic variability. Therefore, the potential metabolic benefit of preoperative carbohydrate loading in patients with type 2 diabetes must be evaluated together with its effects on perioperative glycemic safety.
This study is designed as a single-center, prospective, three-arm, parallel-group randomized controlled trial in adults with type 2 diabetes undergoing elective gastrointestinal surgery. The trial will compare standard ERAS fasting and non-caloric clear-fluid management with preoperative oral carbohydrate loading. A third group receiving an approximately equivalent amount of glucose intravenously is included as a prespecified mechanistic exploratory comparator.
The principal clinical question is whether preoperative oral carbohydrate loading can attenuate early postoperative insulin resistance compared with standard ERAS fasting management. The primary confirmatory comparison is therefore between the oral carbohydrate group and the standard ERAS group. The intravenous glucose group is not the basis for the primary sample-size calculation and will mainly be used to explore whether any observed metabolic effect is related predominantly to glucose substrate provision or whether the oral gastrointestinal route may provide additional metabolic effects.
To reduce treatment-related heterogeneity, perioperative diabetes management will be standardized as much as clinically feasible. Non-insulin glucose-lowering agents will be discontinued before surgery according to the study protocol and current clinical safety requirements, and insulin-based perioperative glucose management will be used when necessary. Use of insulin, including timing, dose, route, and indication, will be carefully documented because exogenous insulin may influence the interpretation of fasting insulin-based measures of insulin resistance.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age 18 to 75 years, regardless of sex. 2.Diagnosis of type 2 diabetes mellitus. 3.Glycated hemoglobin (HbA1c) ≤8.0%, with preoperative fasting plasma glucose generally ≤10.0 mmol/L.
- •4.Scheduled to undergo elective gastrointestinal surgery. 5.Able to wear a continuous glucose monitoring (CGM) device for at least 24 hours before surgery and willing to continue monitoring until hospital discharge or the protocol-specified time point.
- •6.Able to understand the study procedures, voluntarily participate in the study, and provide written informed consent.
排除标准
- •1. Known or highly suspected diabetic gastroparesis, delayed gastric emptying, gastric outlet obstruction, or upper gastrointestinal obstruction.
- •2. Severe gastroesophageal reflux disease or other conditions considered by the investigator to confer a high risk of aspiration.
- •3. Emergency surgery or other non-elective surgery for which the study intervention cannot be implemented as planned.
- •4. Type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
- •5. Pregnancy or breastfeeding.
- •Recent systemic glucocorticoid therapy.
- •Severe hepatic or renal dysfunction, or active severe infection.
- •Inability to comply with CGM use, cognitive or psychiatric conditions preventing completion of study assessments, or anticipated poor adherence to the study protocol.
- •9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
研究组 & 干预措施
Standard ERAS Group
Participants will receive standard ERAS preoperative fasting and non-caloric clear-fluid management without a carbohydrate-containing drink.
干预措施: Standard ERAS Fasting and Clear-Fluid Management (Other)
Oral Carbohydrate Group
Participants will receive 400 mL of a 12.5% maltodextrin solution containing approximately 50 g of carbohydrate before anesthesia.
干预措施: Oral Carbohydrate Loading (Dietary Supplement)
Intravenous Glucose Group
Participants will receive 500 mL of 10% glucose solution containing approximately 50 g of glucose intravenously before anesthesia.
干预措施: Intravenous Glucose (Drug)
结局指标
主要结局
Postoperative Day 1 Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
时间窗: Postoperative day 1
HOMA-IR will be calculated using fasting plasma glucose and fasting serum insulin measured on the morning of postoperative day 1. HOMA-IR will be calculated as fasting plasma glucose (mmol/L) × fasting insulin (μU/mL) / 22.5. Higher values indicate greater insulin resistance.
次要结局
未报告次要终点
研究者
Zhou Yanbing
Director of Surgery, Professor and Chief Physician
The Affiliated Hospital of Qingdao University