Effect of Glucagon-like Peptide 2 on Postprandial Gallbladder Motility in Healthy Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Gallbladder ejection fraction (EF%)
研究概览
简要总结
The study will investigate the effect of the incretin hormone glucagon-like peptide 2 (GLP-2) on postprandial gallbladder motility in young, healthy, male subjects.
The study is double-blinded, randomized and placebo controlled. 15 subjects will be included. On three separate study days (A, B, C) the subjects will receive an four hour intravenous infusion with either saline (placebo), GLP-2 at a rate of 1 pmol/kg/min or GLP-2 at a rate of 10 pmol/kg/min 30 minutes after the infusion start the subject will receive a liquid meal which will stimulate gallbladder contraction.
The gallbladder volume will be determined by frequent ultrasonic scans, and blood samples will be drawn on fixed times through out the study day.
详细描述
Study design The primary endpoint is the incremental Area Under the Curve (iAUC) of the gallbladder Ejection Fraction % (EF) at time 0-210 minutes. Gallbladder volume will be measured during a four hour intravenous GLP-2 infusion at two different concentrations (1 pmol/kg body weight/min and 10pmol/kg body weight/min), respectively, compared to placebo after ingestion of a liquid meal in healthy, young, male subjects. The gallbladder volume will be quantified by multiple ultrasonography scans at fixed times during the experimental study days.
Gallbladder ejection fraction (EF%) will be calculated as following:
Gallbladder EF = (gallbladder volume, baseline - gallbladder volume, at a given time t) / gallbladder volume, baseline * 100. The gallbladder volume is determined by bedside ultrasonography.
15 healthy male subjects will be included according to the inclusion and exclusion criteria listed below.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian ethnicity
- •Age: 18-35 years
- •BMI: 18,5-24,9
- •Fasting plasma glucose ≤ 6 mmol/l
- •Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- •Normal haemoglobin (8,3-10,5 mmol/l)
- •Informed and written consent
排除标准
- •First-degree relatives with type 1 or type 2 diabetes
- •Nephropathy (se-creatinin > 130 μM and/or albuminuria)
- •Liver disease (alanintransaminase (ALAT) or aspartattransaminase (ASAT) > 2 × upper normal limit)
- •Active or recent malignant disease
- •Treatment with medicine that cannot be paused for 1 week
- •Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- •Any condition considered incompatible with participation by the investigators
研究组 & 干预措施
GLP-2 (10pmol/kg/min)
A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10pmol/kg/min
干预措施: GLP-2 (10pmol/kg/min) (Drug)
GLP-2 (1pmol/kg/min)
A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min
干预措施: GLP-2 (1pmol/kg/min) (Drug)
Placebo
A single four hour intravenous infusion with saline water (placebo)
干预措施: Placebo (Drug)
结局指标
主要结局
Gallbladder ejection fraction (EF%)
时间窗: 0-210 minutes
Incremental Area Under the Curve (iAUC) for gallbladder ejection fraction (EF%) at time 0-210 minutes.
次要结局
- Glucagon(-30-200 minutes)
- Gastric emptying(0-200 minutes)
- Time to maximum gallbladder EF%(0-210 minutes)