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临床试验/NCT03658564
NCT03658564Unknown不适用

Preoperative Oral Carbohydrate Treatment in Diabetes Patients: A Randomized, Double-blind Trial

The Second Affiliated Hospital of Dalian Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
VAS

研究概览

简要总结

Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

详细描述

Insulin resistance is a positive protective reaction against surgery . As a response to surgery, activation of neuroendocrine and inflammation systems occurs as a protective reaction. However, this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery

排除标准

  • Weight loss greater than 10 per cent during the previous 6 months
  • Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis)
  • Hepatic insufficiency (Child-Pugh class, ≥ B)
  • Gastro-oesophageal reflux disease
  • Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate

研究组 & 干预措施

Oral carbohydrate

Experimental

fast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.

干预措施: Preoperative Oral Carbohydrate Drink (Dietary Supplement)

Fasting

No Intervention

fast from midnight the night before surgery, and no preoperative oral carbohydrate loading

结局指标

主要结局

VAS

时间窗: 1 day (preoperative period)

Preoperative general well-beings before assessed with the visual analogue scale (VAS).

次要结局

  • HOMA(perioperative period))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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