The Antiemetic Effects of Increased Splanchnic Perfusion, Induced by the Gut Hormone GIP, in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in GLP-1 induced nausea intensity
研究概览
简要总结
This study investigates whether the gut hormone glucose-dependent insulinotropic polypeptide (GIP) can reduce feelings of nausea. GIP is naturally released after meals and is administered intravenously to healthy participants during the experiment. Nausea is induced using either glucagon-like peptide 1 (GLP-1), another gut hormone, or apomorphine, a medication known to trigger nausea. By combining these substances, the study aims to determine whether GIP can alleviate nausea. The findings may improve understanding of interactions between the gut and the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Men or women, age of 18-60 years
- •BMI between 19-27 kg/m2 (both included)
- •informed consent
排除标准
- •Current or past treatment with GLP-1 or GIP/GLP-1 receptor-targeting compounds within the last six months
- •Gastrointestinal disorders that the investigator evaluates could interfere with induction of nausea (e.g. gastroparesis, functional dyspepsia and GI surgery)
- •Neurological disorders affecting nausea (e.g. severe migraines and neuropathy)
- •Any known eating disorders (e.g. anorexia nervosa and bulimia)
- •Pregnancy or breastfeeding
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (> 2 times normal values) or present hepatobiliary disease
- •Kidney disease (estimated glomerular filtration rate (eGFR)<90 ml/min/1.73 m2) at screening
- •Severe arteriosclerotic heart disease or heart failure (NYHA class II-IV)
- •Glycated hemoglobin (HbA1c) ³ 48 mmol/mol and/or diagnosed type 1 or type 2 diabetes
- •Any condition that the investigator evaluates would interfere with study participation
结局指标
主要结局
Change in GLP-1 induced nausea intensity
时间窗: From enrollment to the end of treatment at up to 12 weeks.
The primary endpoint is the change in GLP-1-induced nausea intensity, measured by a 0-100 mm visual analogue scale (VAS), between study visits, with and without GIP infusion.
次要结局
未报告次要终点
研究者
Lærke Smidt Gasbjerg
MD, PhD, Asst. Prof.
University of Copenhagen