Intestinal Glucagon-like Peptide-1 (GLP-1) and the Physiological Role in Eating in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Effect of exendin(9-39)on total calorie intake
研究概览
简要总结
The aim is to further establish a physiological role for GLP-1 as an endogenous satiety signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects.
详细描述
Understanding the exact mechanisms by which GLP-1 inhibits eating can be crucial in order to convert its anorectic action into useful, safe and effective drugs. So far, it is however not clear to what extent GLP-1 is a hormonal regulator of eating or whether the observed effects are rather a pharmacological phenomenon. By applying classical algorithms from endocrinology several criteria must be fulfilled before a hormone can be considered an endogenous physiological satiety signal. One is that exogenous administration of a selective antagonist should prevent the eating-inhibitory effect of GLP-1. At present, cholecystokinin (CCK) is the only peptide in humans identified to fit these criteria. For intestinal GLP-1, it has not been investigated whether a specific GLP-1 receptor antagonist can block the eating-inhibitory effect in humans. The availability of a specific GLP-1 receptor antagonist, exendin (9-39), now makes it possible to further investigate this pathway. Exendin (9-39), is a powerful tool available for human use to characterize of endogenous GLP-1 as a physiological regulator of different biological functions. The molecule has been used to document that endogenous GLP-1 is an important incretin hormone and a regulator of antro-pyloro-duodenal motility. The role of endogenous GLP-1 in regulating food intake and appetite has, however, not been investigated before.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject with a BMI of 19-25 m2/kg
- •Stable body weight for at least three months
- •Normal eating habits
- •Age between 18 and 45 years
- •Sufficient understanding of the German language
- •Subjects understand the procedures and the risks associated with the study
- •Participants must be willing to adhere to the protocol and sign the consent form
排除标准
- •Participation in another clinical trial (currently or within the last 30 days)
- •Substance abuse
- •Regular intake of medications (except for oral contraceptives)
- •Chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values
- •History of gastrointestinal disorders
- •Food allergies
研究组 & 干预措施
iv saline, intraduodenal saline
intravenous infusion of saline plus intraduodenal administration of saline
干预措施: Saline (Dietary Supplement)
IV exendin(9-39) plus intraduodenal (ID) saline
intravenous infusion of exendin(9-39) plus intraduodenal administration of saline
干预措施: Exendin 9-39 (Drug)
IV saline, intraduodenal nutrient
intravenous infusion of saline plus intraduodenal administration of nutrient
干预措施: Saline (Dietary Supplement)
Exendin(9-39) plus ID nutrient
Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration
干预措施: Exendin(9-39) plus ID nutrient (Drug)
结局指标
主要结局
Effect of exendin(9-39)on total calorie intake
时间窗: 60 min test meal
Effect of exendin(9-39) on total fluid intake
时间窗: 60 min test meal
Effect of exendin(9-39)on meal duration during an ad libitum test meal.
时间窗: 60 min test meal
次要结局
- Effect of exendin(9-39)on plasma concentration of glucose(4 hours blood sampling)
- Effect of exendin(9-39)on plasma concentration of insulin.(4 hours blood sampling)
- Effect of exendin(9-39)on plasma concentration of glucagon.(4 hours blood sampling)
- Effect of exendin(9-39)on plasma concentration of GLP-1.(4 hours blood sampling)
- Effect of exendin(9-39)on plasma concentration of peptide tyrosine tyrosine (PYY).(4 hours blood sampling)
- Effect of exendin(9-39)on plasma concentration of CCK.(4 hours blood sampling)
- Effect of exendin(9-39)on plasma concentration of ghrelin.(4 hours blood sampling)