Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Fibroblast growthfactor-21
研究概览
简要总结
Plasma fibroblast growthfactor-21 (FGF21) responses to acute alcohol exposure will be evaluated in three groups: A: 15 individuals diagnosed with alcohol dependence (ICD10 code F10.2) and no alcoholic liver diseases, B: 15 healthy individuals with one or two parents with alcohol dependence, and C: 15 healthy matched controls without history of or disposition to alcohol dependence. The experimental day consists of a load of 0.5 g ethanol per kg body weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using visuel analogue scale and resting energy expenditure will be evaluated using indirect calorimetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Caucasian males between 25 and 65 years of age
- •BMI between 19 and 27 kg/m2
- •Normal haemoglobin
- •Normal fasting plasma glucose concentration (< 6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (< 42 mmol/mol)
- •Participants with a father diagnosed with alcohol dependence (group B):
- •Father diagnosed with alcohol dependence
- •Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
- •Normal Alcohol Use Disorders Identification Test (AUDIT) score
- •Healthy participants (group C):
- •Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
- •Normal AUDIT score
排除标准
- •Liver disease evaluated by plasma alanine aminotransferase (ALAT) > 3 × normal level, an international normalised ratio (INR) below normal values, or biopsy-verified alcoholic liver disease
- •Diabetes mellitus
- •Nephropathy
- •Other diseases the investigator finds disruptive for participation in the study.
- •Participants with a father diagnosed with alcohol dependence (group B):
- •- Former alcohol dependence or abuse
- •Healthy participants (group C):
- •First-degree relatives with diabetes, liver disease and/or alcohol dependence
- •Former alcohol dependence
结局指标
主要结局
Fibroblast growthfactor-21
时间窗: One year
Plasma FGF21 concentrations, a member of the endocrine FGF-family
次要结局
- Ethanol(One year)
- Glucose(One year)
- Insulin and C-peptide(One year)
- Glucagon(One year)
- Lipopolysaccharide Binding Protein (LBP)(One year)
- Tumor Necrosis Factor-alpha (TNF)(One year)
- Interferon-gamma (INF)(One year)
- Interleukine-8 (IL-8)(One year)
- Interleukine-6 (IL-6)(One year)
- Interleukine-10 (IL-10)(One year)
研究者
Filip Krag Knop
Head of Clinical Metabolic Physiology, Principal Investigator, Clinical Professor, PhD, MD
University Hospital, Gentofte, Copenhagen