A Multicenter Randomized Controlled Study of Preoperative Oral Administration of Branched-chain Amino Acids in Reducing Postoperative Insulin Resistance in Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- The proportion of postoperative blood glucose>8mmol/L
研究概览
简要总结
Postoperative insulin resistance refers to the phenomenon that the body's glucose uptake stimulated by insulin is reduced due to stress effects such as trauma or the inhibitory effect of insulin on liver glucose output is weakened after surgery.
There is a clear link between postoperative insulin resistance and poor perioperative prognosis. Therefore, exploring interventions to reduce postoperative stress insulin resistance, stabilize postoperative blood glucose, and reduce postoperative complications are clinical problems that need to be solved urgently. In recent years, research on branched-chain amino acids and metabolic diseases has become a hot spot. Studies have found that in the rat model, preoperatively given a high branched-chain amino acid diet can inhibit postoperative insulin resistance and stabilize blood glucose levels. This research plan is to try to add branched-chain amino acids before surgery to observe the occurrence of postoperative insulin resistance in patients.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 years old ;
- •Clinical diagnosis of colorectal cancer;
- •Planned elective laparoscopic radical resection of colorectal cancer;
- •Preoperative American Society of Anesthesiologists（ASA）score grade I-III ;
- •Informed consent was obtained from patients.
排除标准
- •Clinical diagnosis of Diabetes mellitus;
- •Preoperative insulin resistance ;
- •Renal insufficiency requires dialysis, hepatic insufficiency (Child - Pugh grade B and above);
- •Eating disorders caused by gastrointestinal obstruction;
- •Pregnant or lactating women;
- •Patients with severe mental illness.
研究组 & 干预措施
control group
600ml water was consumed by patients 2-4h before suegery.
干预措施: water (Dietary Supplement)
research group
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
干预措施: BCAA (Dietary Supplement)
结局指标
主要结局
The proportion of postoperative blood glucose>8mmol/L
时间窗: 1 day
The proportion of postoperative blood glucose\>8mmol/L.Measure method：Continuous blood glucose meter.
次要结局
- Postoperative blood glucose(1 day)
- Homeostasis model assessment - insulin resistance （HOMA-IR）(1 day)
- Postoperative complications(1 month)
- Postoperative hospital stay(1 month)
研究者
Sun Peng
Executive Director of General Surgery
Shanghai Tong Ren Hospital