NCT03009916已完成4 期
Bileacid Malabsorption and GLP-1 Secretion
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- GLP-1
研究概览
简要总结
The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Northern European origin
- •Normal haemoglobin
- •Age above 18 years and below 70 years
- •Informed and written consent
- •BMI > 23 kg/m2 and < 35 kg/m2
- •Normal fasting plasma glucose (FPG) < 6.5 mM) and glycated haemoglobin (HbA1c) < 48 mmol/mol
排除标准
- •Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- •Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- •First-degree relatives with diabetes
- •Nephropathy (serum creatinine >150 µM and/or albuminuria
- •Treatment with medicine that cannot be paused for 12 hours
- •Hypothyroidism or hyperthyroidism
- •Treatment with oral anticoagulants
- •Active or recent malignant disease
- •Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- •Lack of effective birth control in premenopausal women
- •Any condition considered incompatible with participation by the investigators
研究组 & 干预措施
Healthy controls
Other
Healthy controls found according to the protocol
干预措施: "cholestagel®" (Colesevelam) (Drug)
Healthy controls
Other
Healthy controls found according to the protocol
干预措施: Placebos (Drug)
Patients with BAM
Other
Patients with bile acid malabsorption found according to the protocol
干预措施: "cholestagel®" (Colesevelam) (Drug)
Patients with BAM
Other
Patients with bile acid malabsorption found according to the protocol
干预措施: Placebos (Drug)
结局指标
主要结局
GLP-1
时间窗: 240 min
次要结局
未报告次要终点
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen
研究点 (1)
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