NCT06608433已完成不适用
Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年1月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in serum cortisol after Rybelsus vs. Placebo
研究概览
简要总结
This study aims to investigate the effects of a single dose of the glucagon-like 1 receptor agonist semaglutdie/Rybelsus on the hypothalamo-pituitary-adrenal axis, thus cortisol levels and other stresshormones in healthy males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18-60 years
- •BMI 18.5-30 kg/m2
- •No regular medication
排除标准
- •participation in a trial with investigational drugs within 30 days
- •vigorous physical exercise within 24 hours before the study participation
- •alcohol intake within 24 hours before the study participation
- •a history of intake of glucocorticoids or GLP-1 RA within the last 8 weeks.
- •Known allergy towards GLP-1 RA
研究组 & 干预措施
Semaglutide/Rybelsus
Experimental
干预措施: semaglutide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in serum cortisol after Rybelsus vs. Placebo
时间窗: within 210 minutes after the intake of the study drug
The primary endpoint is the difference between the two visits (placebo vs. Rybelsus) in the change in cortisol from cortisol baseline to the maximally stimulated cortisol value (cortisolmax).
次要结局
未报告次要终点
研究者
研究点 (1)
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