NCT07821515招募中不适用
Does Paracetamol Influence the Release of Gut Hormones, Glucose Absorption and Glycemia?
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Glucagon-like peptide 1
研究概览
简要总结
The study aim is to determine whether acute inhibition of endogenous prostaglandin synthesis by paracetamol affects the release of gut hormones, glucose absorption and glycemia in healthy young individuals
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
identical capsules containing Paracetamol and placebo is prepared by the pharmacy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Nondiabetic fasting plasma glucose (< 7.0 mmol/L) at time of inclusion
- •BMI of 20-25
- •Written informed consent
排除标准
- •Haemoglobin < 7.9 mmol/L
- •Pregnancy or breastfeeding
- •Significant gastrointestinal symptoms (e.g. dyspepsia, postprandial pain)
- •Use of medication that cannot be paused for 12 hours or any drug that affects gastric emptying, small intestinal motility, glucose absorption.
- •Use of paracetamol, NSAID, aspirin or similar within the previous week.
- •Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20g alcohol
- •History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery including cholecystectomy (but not uncomplicated appendicectomy)
- •Participation in other research studies within the previous 3 months
- •Inability to give informed consent
- •Intolerance to any of the components of paracetamol and the meals used for the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Paracetamol (1000mg)
Active Comparator
干预措施: Paracetamol (Other)
结局指标
主要结局
Glucagon-like peptide 1
时间窗: From baseline samples (-15, 0 min) until the end of the meal test at t = 180min
Plasma concentration
次要结局
- Glucose(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- Gastrin(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- Cholecystokinin(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- Glucose-dependent insulinotropic polypeptide (GIP)(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- C-peptide(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- Glucagon(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- Pancreatic polypeptide(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
- 3-OMG(From baseline samples (-15, 0 min) until the end of the meal test at t = 180min)
研究者
Simon Veedfald
Assistant professor
University of Copenhagen
研究点 (2)
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