The Effect of Exogenous Glucagon-like Peptide 2 on Cholecystokinin-induced Gallbladder Emptying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Gallbladder volume
研究概览
简要总结
The study is a randomized, double-blinded, placebo-controlled, cross-over study, which will investigate the acute effects of the gut-derived hormone glucagon-like peptide 2 (GLP-2) on cholecystokinin (CCK)-induced gallbladder emptying. Furthermore, the investigators will investigate different hormonal responses and appetite during the study days.
The investigators hypothesize that GLP-2 will overrule the potent gallbladder relaxing effect of CCK.
We will include 15 healthy male participants, and each of the participants will participate in four study days. GLP-2 and CCK will be given intravenously, and will be placebo-controlled. Gallbladder volume will be determined by frequent ultrasonography scans. Appetite will be assessed by Visual Analog Scales through out the study day and an ad libitum meal at the end of the study day. Blood samples will be drawn at regular intervals to asses different hormonal responses.
详细描述
Background
AIM OF THE STUDY The aim of the study is to investigate if exogenous GLP-2 can overrule CCK-induced gallbladder contraction
STUDY DESIGN The study is a randomized, double-blinded, placebo-controlled, crossover study enrolling 15 healthy participants. Each participant will undergo four separate study days in randomized order. Each study day encompasses two intravenous (iv) infusions, one with CCK (0.4 pmol × kg^-1 × min^-1) or placebo (saline), and one with GLP-2 (10 pmol × kg^-1 × min^-1) or placebo (saline): Day A, CCK + GLP-2; Day B, CCK + placebo; Day C, placebo + GLP-2; Day D, placebo + placebo.
METHODS For each participant, the study consists of an information visit, a screening visit and four experimental days within a time period of minimum 2 months, and with a minimum of three days between each experimental day with procedures explained below.
RECRUITMENT OF PARTICIPANTS Relevant persons, who have previously participated in trials at the investigators research facility and at that time accepted to be contacted again regarding other research projects will be contacted by telephone or e-mail. Alternatively, advertisements regarding the project will be published at www.forsoegsperson.dk, other relevant internet / social media pages and/or local or national newspapers. Persons responding positively will receive the written information. A couple of days after receiving the written information, the potential participant will be contacted and, if the person is still interested in participating, an information visit will be arranged. If the person decides to participate, written consent will be obtained. Obtaining of written consent will be postponed if the potential participant requires more time for consideration. After obtaining written consent the date for the screening visit is planned.
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
- Double (Participant, Investigator)
盲法说明
Day A, B, C and D will be conducted in a randomized and double-blinded order (blinded for the participant and the investigator). The infusion order will be unblinded after the last patient last visit.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian ethnicity
- •Male gender
- •Age 18-65 years
- •Body mass index (BMI) 18.5-24.9 kg/m2
- •Fasting plasma glucose ≤6 mmol/l and glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- •Normal hemoglobin (males 8.3-10.5 mmol/l)
- •Informed and written consent
排除标准
- •Nephropathy (eGFR < 90 ml/min/1.73m2 and/or albuminuria)
- •Known liver disease and/or alanine aminotransaminase (ALAT) and/or aspartate transaminase (ASAT) > 2 × upper normal reference limit
- •Active or recent (within 5 years) malignant disease
- •Any history of colon cancer
- •Treatment with medicine that cannot be paused for 1 week
- •Active tobacco smoking
- •Any condition considered incompatible with participation by the investigators
结局指标
主要结局
Gallbladder volume
时间窗: 0 to 240 minutes
Baseline subtracted area under the curve for gallbladder volume
次要结局
- Bile Acids(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- Triglycerides(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- Cholesterols(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- Heart rate(-15, 0, 30, 60, 90, 120, 150, 180 and 240 minutes)
- CCK(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- GLP-2(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- C-peptide(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- Plasma glucose(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- Appetite(240-270 minutes)
- Maximum gallbladder ejection fraction(0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 195, 210 and 240 minutes)
- Insulin(-15, 0, 10, 30, 40, 50, 70, 100, 140, 180, 210 and 240 minutes)
- Blood pressure(-15, 0, 30, 60, 90, 120, 150, 180 and 240 minutes)
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen