Preoperative Carbohydrate Loading in Patients With Well-controlled Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Capillary blood glucose level (mmol/L) at 4 hours after carbohydrate ingestion
研究概览
简要总结
This prospective, randomized, open-label, parallel-group clinical trial aims to evaluate the safety and metabolic effects of preoperative carbohydrate loading in patients with well-controlled type 2 diabetes mellitus (T2DM) undergoing elective surgery.
The study is conducted at Nhan Dan Gia Dinh Hospital (Ho Chi Minh City, Vietnam) over a 20-month period (March 2023-October 2025). Eligible participants are adults aged 18-65 years with well-controlled T2DM (HbA1c <7%, fasting plasma glucose 6.5-10 mmol/L) and no risk factors for aspiration or gastroparesis.
Participants are randomly assigned to two groups: the intervention group receives 200 mL of 25% carbohydrate solution 2 hours before anesthesia, while the control group follows standard preoperative fasting. Capillary blood glucose is measured at baseline and at 1, 2, and 4 hours after ingestion. Preoperative gastric volume is assessed by bedside ultrasonography to detect residual gastric contents.
The primary outcome is capillary blood glucose level at 4 hours after carbohydrate ingestion. Secondary outcomes include total intravenous insulin used for hyperglycemia management and the proportion of patients with gastric residual volume >1.5 mL/kg.
This study hypothesizes that preoperative carbohydrate loading in well-controlled T2DM patients increases blood glucose by no more than 2 mmol/L at 4 hours after ingestion compared to fasting, without increasing gastric residual volume or aspiration risk.
The results are expected to provide additional evidence on the safety of preoperative carbohydrate loading in diabetic patients, supporting its inclusion in Enhanced Recovery After Surgery (ERAS) protocols for optimized perioperative care.
详细描述
Preoperative carbohydrate loading has been widely recognized as a core component of Enhanced Recovery After Surgery (ERAS) protocols. In non-diabetic patients, drinking a carbohydrate solution two hours before anesthesia improves perioperative metabolic status, reduces insulin resistance, and enhances postoperative recovery without increasing the risk of aspiration or other complications. However, its safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) remain controversial due to concerns about delayed gastric emptying and hyperglycemia.
Recent studies have shown that preoperative carbohydrate drinks in patients with well-controlled T2DM do not significantly delay gastric emptying and cause only transient increases in blood glucose levels, typically returning to baseline within 180 minutes. These findings suggest that carbohydrate loading may be safe for this population, provided their diabetes is well managed and they have no symptoms of gastroparesis. Despite this, current guidelines remain cautious, and further evidence is needed to strengthen clinical recommendations, particularly in Asian populations.
This randomized, open-label, parallel-group clinical trial is being conducted at Nhan Dan Gia Dinh Hospital, Ho Chi Minh City, Vietnam. The study enrolls adult patients (aged 18-65 years) with well-controlled T2DM (HbA1c <7%, fasting glucose 6.5-10 mmol/L) scheduled for elective surgery under general anesthesia. Participants are randomly assigned in a 1:1 ratio to receive either 200 mL of 25% carbohydrate solution two hours before anesthesia (intervention group) or to continue standard fasting for at least six hours before surgery (control group). Randomization is performed using computer-generated allocation.
Capillary blood glucose levels are measured at baseline and at 1, 2, and 4 hours after ingestion. Bedside gastric ultrasonography is used to estimate gastric volume before anesthesia, and residual volume greater than 1.5 mL/kg is considered gastric retention. Patients with capillary glucose >10 mmol/L persisting beyond 180 minutes will receive intravenous insulin infusion according to the hospital protocol.
The primary endpoint is capillary blood glucose level at four hours after carbohydrate ingestion. Secondary outcomes include total insulin administered to treat hyperglycemia and the proportion of participants with gastric retention before anesthesia. Safety outcomes include incidence of aspiration, diabetic ketoacidosis, and other adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years scheduled for elective surgery under general anesthesia.
- •Diagnosed with type 2 diabetes mellitus with well-controlled glycemia (HbA1c < 7% within the last 3 months).
- •Fasting plasma glucose between 6.5 and 10 mmol/L on the day before surgery.
- •ASA physical status II-III.
- •Capable of oral intake and able to provide written informed consent.
- •No contraindication to carbohydrate ingestion or ultrasonographic gastric assessment.
排除标准
- •History or clinical evidence of gastroparesis, gastroesophageal reflux disease (GERD), or hiatal hernia.
- •Conditions increasing aspiration risk: obesity (BMI > 30 kg/m²), pregnancy, or emergency surgery.
- •Severe systemic comorbidities (renal failure, hepatic failure, heart failure, or COPD exacerbation).
- •Use of medications affecting gastric motility (opioids, prokinetics, anticholinergics) within 24 hours.
- •Known hypersensitivity or intolerance to carbohydrate drink components.
- •Refusal or inability to participate.
研究组 & 干预措施
Standard fasting group
Participants fast for at least six hours before anesthesia, following standard preoperative fasting guidelines.
Capillary blood glucose is measured at baseline, and at 1, 2, and 4 hours before surgery.
Carbohydrate loading group (25% carbohydrate solution)
Participants receive 200 mL of 25% carbohydrate solution two hours before anesthesia.
Capillary blood glucose is measured at baseline, and at 1, 2, and 4 hours after ingestion.
Preoperative gastric ultrasonography is performed 2 hours after ingestion to assess residual gastric volume.
干预措施: 25% Carbohydrate solution (CHO drinking) (Dietary Supplement)
结局指标
主要结局
Capillary blood glucose level (mmol/L) at 4 hours after carbohydrate ingestion
时间窗: 4 hours post-ingestion
Measured by capillary blood sample using ACCU-CHEK Active device. The endpoint tests the non-inferiority hypothesis that glucose elevation does not exceed +2 mmol/L compared to the control group.
次要结局
- Capillary blood glucose levels at 1 and 2 hours after ingestion(1 and 2 hours post ingestion)
- Total intravenous insulin administered for hyperglycemia (>10 mmol/L)(Up to 4 hours after ingestion)
- Proportion of patients with gastric retention (GV/W >1.5 mL/kg)(Preoperative (2 hours after ingestion))