Treatment of Bile Acid Malabsorption With Liraglutide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in stool fequency
研究概览
简要总结
Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam
详细描述
The overall objective of the present study is to provide proof of concept that treatment with the GLP-1 receptor agonist liraglutide is efficacious (as assessed by symptom relief, i.e. response to treatment) and safe (as assessed by adverse effects) in the management of BAM and that it improves bile acid reabsorption (as assessed by SeHCAT) in these patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Caucasian ethnicity
- •SeHCAT-verified moderate (5-10% bile acid retention after 7 days) or severe BAM (<5% retention)
- •Normal haemoglobin (for men 8.3-10.5 mmol/L; for women 7.3-9.5 mmol/L)
- •Age above 18 years and below 75 years
- •Informed and written consent
- •BMI >18,5 kg/m2 and <40 kg/m2
- •Glycated haemoglobin (HbA1c) <48 mmol/mol
排除标准
- •• History of or present hepatobiliary disorder (except for non-alcoholic steatotic liver disease) and/or alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 times upper limit of normal) or history of hepatobiliary disorder
- •Gastrointestinal disease (except for BAM), previous intestinal resection or any major intra-abdomial surgery
- •Diabetes mellitus
- •Nephropathy with eGFR < 60 mL/min/1.73m2
- •Treatment with medicine that cannot be paused for 12 hours
- •Hypothyroidism or hyperthyroidism, if not well regulated.
- •Treatment with oral anticoagulants
- •Active or recent malignant disease
- •Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- •Females of child-bearing potential who is pregnant (tested before entering the study), breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes Intrauterine Device (IUD), birth control pills, sexual abstinence or living in a relationship with a sterile partner.
- •Known or suspected hypersensitivity to trial products or related products
- •Any condition considered incompatible with participation by the investigators
研究组 & 干预措施
Liraglutide/placebo-colesevelam
Liraglutide as active and colesevelam as placebo
干预措施: Liraglutide 6 MG/ML (Drug)
Placebo-Liraglutide/colesevelam
Liraglutide as placebo and colesevelam as placebo
干预措施: Colesevelam (Drug)
结局指标
主要结局
Change in stool fequency
时间窗: 7 weeks
Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode
次要结局
- Change in SeHCAT(7 weeks)
- Total symptoms score, quality of life scores, and biomarker.(7 weeks)
- Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea(7 weeks)
研究者
Filip Krag Knop
Professor, Consultant Endocrinologist, MD PhD
University Hospital, Gentofte, Copenhagen