Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery: A Randomised Doubled-blinded Control Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Insulin Sensitivity
研究概览
简要总结
The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective hip replacement
排除标准
- •Known diabetes mellitus
- •Kidney failure (creatinine clearance <40 ml/min
- •Liver failure (aspartate and alanine aminotransferases x 2 above reference)
- •Hb <110 g/l
- •Ongoing severe bacterial or viral infection
- •Malignancies
- •Psychiatric disease
研究组 & 干预措施
PreOp, NutriciaNordica AB
PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
干预措施: Experimental: PreOp, NutriciaNordica AB (Dietary Supplement)
Water
Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
干预措施: Placebo Comparator: Water (Dietary Supplement)
结局指标
主要结局
Change in Insulin Sensitivity
时间窗: Morning before surgery and up to two days after surgery
Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp
次要结局
- Change in Beta Cell Function(Morning before surgery and up to two days after surgery)
研究者
Thomas Nystrom
MD
Karolinska Institutet