Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- changes in plasma insulin and glucose levels
研究概览
简要总结
Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. To avoid these harmful effects of starvation, patients are now given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2 hours before the operation. These drinks have been shown to make patients feel better, reduce sickness after the anesthetic/surgery and result in quicker recovery from operation. But the ways in which the sugar drinks have these beneficial effects on the body are unknown. The optimum time of giving these drinks to patients before operation is also unknown. This study will investigate the hormone responses of the body, following intake of 2 different carbohydrate drinks, in order to determine the optimum time of intake of these drinks in order to obtain the maximum benefits for the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male Caucasian volunteers aged 18-40 years,
- •BMI of 20-25 kg/m2,
- •able to give voluntary written informed consent to participate in the study, - able to understand the requirements of the study, including anonymous publications, AND
- •agree to co-operate with the study procedure.
排除标准
- •any history of acute or chronic illness, smoking, regular medication or substance abuse, OR
- •have taken part in any other clinical study within the previous 3 months.
结局指标
主要结局
changes in plasma insulin and glucose levels
时间窗: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)
次要结局
- Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations(For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours))