2024-518641-21-00招募中4 期
The effect of liraglutide on MMC activity, gastrointestinal hormones, hunger ratings and ad libitum food intake in healthy volunteers.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To detect changes in MMC activity after the administration of liraglutide compared to placebo.
研究概览
简要总结
To detect changes in migrating motor complex (MMC) activity after administration of liraglutide compared to placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subject is female or male between 18 and 65 years of age.
- •Subject has a BMI between 18 and 25 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
- •Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •Subject is under age of legal consent, pregnant or breastfeeding.
- •History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
- •Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men.
- •Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
- •High caffeine intake (> 500 ml coffee daily or equivalent).
- •Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
- •Recent participation (<30 days) or simultaneous participation in another clinical study.
- •Subject with a BMI ≤ 18 kg/m² or BMI ≥ 25 kg/m².
- •Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- •Subject has diabetes.
- •Subject has a significant heart, lung, liver or kidney disease.
- •Subject has any history of a neurological disorder.
- •Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
- •Subject shows abnormal eating behavior or has an eating disorder.
- •History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
结局指标
主要结局
To detect changes in MMC activity after the administration of liraglutide compared to placebo.
To detect changes in MMC activity after the administration of liraglutide compared to placebo.
次要结局
- A difference in gastrointestinal hormone release compared between placebo and liraglutide treatment
- A difference in hunger sensations compared between placebo and liraglutide treatment
- A difference in ad libitum food intake compared between placebo and liraglutide treatment
- A difference in whole blood glucose levels compared between placebo and liraglutide treatment
研究者
Jan Tack
Scientific
UZ Leuven
研究点 (1)
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