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临床试验/NCT04013594
NCT04013594已完成不适用

Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients

Yonsei University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Glycemic variability

研究概览

简要总结

Preoperative carbohydrate drink intake attenuate insulin resistance. However, carbohydrate loading may compromise blood glucose control in patients with diabetes. There is some evidence that oral carbohydrate loading may be safe in patients with type 2 diabetes. Therefore, the investigators aim to evaluate whether preoperative carbohydrate intake affects insulin resistance and glycemic variability in patients with diabetes. Fifty patients scheduled for total knee arthroplasty will be divided into carbohydrate (n=25) and control (n=25) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 hours before surgery according to standard protocol.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing total knee arthroplasty

排除标准

  • Patients with contraindications to spinal anesthesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
  • Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
  • Patients with chronic renal disease or severe cardiovascular disease
  • HbA1c >69 mmol/mol or BMI >30 kg/m2
  • A duration of ≥5 hours between consumption of CHO and initiation of surgery.
  • The subject is a foreigner or illiterate

结局指标

主要结局

Glycemic variability

时间窗: 1 hour after surgery

- Coefficient of glucose variability =SD/mean x 100 (%)

次要结局

  • gastric volume(Before anesthesia)
  • hand grip strength(Before anesthesia)
  • Insulin resistance(Before anesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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