The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Alcohol preference (How much do you want to drink alcohol?)
研究概览
简要总结
The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Informed consent
- •Caucasian male
- •Body mass index between 19 and 27 kg/m2
- •Normal haemoglobin and normal glycated haemoglobin A1c (HbA1c) (< 42 mmol/mol)
- •Weekly alcohol intake of less than 14 units of alcohol (1 unit = 12 g ethanol)
排除标准
- •Liver diseases evaluated by plasma alanine aminotransferase (ALAT) > 3 × normal level or an International Normalized Ratio (INR) below normal values
- •Diabetes mellitus
- •Nephropathy
- •First-degree relatives with diabetes and/or liver diseases and/or alcohol use disorder
- •Other diseases the investigator finds disruptive for participation in the study
结局指标
主要结局
Alcohol preference (How much do you want to drink alcohol?)
时间窗: 1 year
Evaluated by Visual analogue scale from "not at all" to "more than ever"
次要结局
- Plasma bone marker concentration(1 year)
- Resting energy expenditure(1 year)
- Plasma glucagon concentration(1 year)
- Plasma lipid profile(1 year)
- Serum insulin concentration(1 year)
- Plasma glucose concentration(1 year)
- Plasma fibroblast growth factor-21 concentration(1 year)
- Serum C-peptide concentration(1 year)
- Plasma insulin-like growth factor 1 concentration(1 year)
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen