NCT03348371已完成不适用
The Effects of Orally Ethanol vs. Isoethanolaemic i.v. Infusion of Ethanol on Intestinal Permeability and Gut Hormones
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Serum insulin level
研究概览
简要总结
The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian male between 20 and 50 years of age
- •Body mass index (BMI) between 19 and 25 kg/m2
- •Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
- •Normal fasting plasma glucose concentration (i.e. <6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (i.e. ≤42 mmol/mol)
- •Normal haemoglobin
- •Informed consent
排除标准
- •First-degree relatives with diabetes and/or liver disease
- •Liver disease or other alcohol-related diseases, diabetes mellitus
- •Liver disease (serum ALAT and/or serum ASAT >2 × normal values)
- •Nephropathy (serum creatinine above normal range and/or albuminuria)
研究组 & 干预措施
i.v. infusion day
Experimental
Participant receive ethanol in an i.v. infusion
干预措施: Ethanol (Other)
Oral day
Experimental
Participant receive ethanol orally
干预措施: Ethanol (Other)
结局指标
主要结局
Serum insulin level
时间窗: 2 month
difference in serum insulin level between the two administration forms
次要结局
未报告次要终点
研究者
Amalie Lanng
BA
University of Copenhagen
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