GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans: Native GLP-1 Compared With Analogue ROSE-010 in Vitro
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
- 2
- 主要终点
- Motility index (measure of contraction amplitude x duration; area for mmHg x sec)
研究概览
简要总结
The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.
详细描述
Twelve healthy volunteers will undergo antroduodenojejunal manometry. Baseline recording with infusion of saline for 1 hour is compared with infusion of GLP-1 0.7 and 1.2 pmol per kg minute for another 1 hour. Plasma GLP-1 and GLP-2 is measured by RIA. Responses to GLP-1 will be measured after food intake as prandial response to GLP-1. The outcome will be evaluated as change in motility index from baseline to meal-stimulated conditions and during influence of GLP-1. Further in vitro studies of gastrointestinal muscle strips, precontracted with bethanechol or electric field stimulation, are planned to investigate the response to GLP-1 or GLP-1 analogue ROSE-010. GLP-1 and GLP-2 receptor immunoreactivity is localized by immunohistochemistry. Receptor mediated mechanisms are studied with GLP-1 receptor blocker exendin(9-39)amide, nitro-monomethyl arginine to block nitric oxide synthase and tetrodotoxin to block sodium channels and nerve conduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers over 18 years of age.
排除标准
- •Any medical condition.
- •Any drug treatment.
研究组 & 干预措施
GLP-1
Intravenous infusion of GLP-1 at 0.7 and 1.2 mol/kg per minute
干预措施: GLP-1 (Biological)
Control
Intravenous saline
干预措施: Intravenous saline (Biological)
结局指标
主要结局
Motility index (measure of contraction amplitude x duration; area for mmHg x sec)
时间窗: 60 minutes
Inhibition of prandially increased motility index (motor activity in the antrum and upper small intestine).
次要结局
- Presence of GLP-1 and GLP-2 receptors in gastric and small bowel tissue(1 day)
- Smooth muscle relaxation induced by GLP-1(6 hours)
研究者
Per Hellström
Professor
Uppsala University