Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pancreatic beta-cell function
研究概览
简要总结
A body of epidemiologic studies show that moderate alcohol consumption is associated with a protective effect against type 2 diabetes. The importance of both insulin sensitivity and insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely recognized. Clinical studies show improved insulin sensitivity after a period of alcohol consumption compared to abstention. However, postprandial insulin secretion and beta-cell function after a period of moderate alcohol consumption have scarcely been addressed in published literature.
When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate appetite and food intake and thus might be a risk factor for over consumption and obesity. However the physiological mechanisms for this observed effect are not well understood. Furthermore, previous studies lacked a link between physiological parameters and subjective parameters of satiety.
详细描述
Objective:
Primary objectives are to study the effects of moderate alcohol consumption on
- Postprandial insulin secretion and pancreatic beta-cell function
- Physiological and subjective parameters related to satiety and appetite
Secondary objectives are to study the effects of moderate alcohol consumption on
- Miscellaneous markers of glucose homeostasis and insulin sensitivity
- Kinetics of alcohol-induced increase of adiponectin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Apparently Females between 20 - 44 years of age
- •Using oral contraceptives for >3 months (only phase 1 or 2 oral contraceptives)
- •Normal fasting glucose levels as indicated by venous fasting plasma glucose levels < 6.1 mmol/L
- •Alcohol consumption more or equal then 5 and less than 22 glasses/week
- •Body Mass Index (BMI) between 19 and 25 kg/m2
排除标准
- •Having the intention to become pregnant, to be pregnant or to lactate during the study
- •Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders
- •Having a family history of alcoholism
- •Reported use of any soft or hard drugs
- •Reported unexplained weight loss or gain of > 3 kg in the month prior to the screening
结局指标
主要结局
Pancreatic beta-cell function
时间窗: 3 weeks of treatment preceded by a 1-week wash-out
Satiety
时间窗: 3 weeks of treatment preceded by a 1-week wash-out
次要结局
- Kinetics of adiponectin(3 weeks of treatment preceded by a 1-week wash-out)