INGEAR-1: Effects of INtravenous Infusions of PYY3-36 and GLP-1, as Monoinfusion and in Combination, on ad Libitum Energy Intake, Appetite Sensation, and Energy Expenditure in Healthy Obese Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Ad libitum energy intake
研究概览
简要总结
The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men age 18-50 years
排除标准
- •Diabetes mellitus
- •psychological illness
- •on special diets (eg vegetarian, Atkins)
- •weight change of >3kg within the 2 months prior to screening
- •Hypothalamic or genetic aetiology of obesity
- •diagnosed cancer
- •chronic illness or disease
- •Eating disorder (anorexia or bulimia)
- •substance abuse
- •Use of any prescription or over the counter medication that can affect metabolism
- •Excessive intake of alcohol (>7 drinks/week)
- •Excessive intake of caffeine (>300 mg/day)
- •High level of physical activity (>10 hours/week)
- •Lack of desire or willingness to take part in and follow study protocol
研究组 & 干预措施
GLP-1
Study participants will receive a 3 hour IV infusion of PYY3-36 while fasting.
干预措施: GLP-1 (Biological)
PYY3-36 + GLP-1
Study participants will receive a 3 hour IV infusion of (GLP-1 + PYY3-36) while fasting.
干预措施: GLP-1 (Biological)
结局指标
主要结局
Ad libitum energy intake
时间窗: Immediately following 3h IV infusion
次要结局
- Energy expenditure (ventilated hood technique).(During 3h IV infusion)
- Changes in levels of glucose, insulin, C peptide, GIP, leptin, ghrelin, adiponectin, cholecystokinin(Prior to, and 15, 30, 60, 90, 120, 180 mins during IV infusion)
- Appetite sensation by visual analog scale(Every 30 minutes during 3h IV infusion)
- Gastric emptying (paracetamol)(At time=15, 30, 60, 90, 120, 180 mins during IV infusion)
研究者
AAstrup
Professor, MD
University of Copenhagen