Treatment of bile acid malabsorption with liraglutid

Professor, Ph.d. MD. Filip Krag Knop0 个研究点目标入组 50 人开始时间: 2018年10月19日最近更新: 2021年3月17日

试验速览

暂无简介。

•Caucasian ethnicity
•SeHCAT-verified moderate (5–10% bile acid retention after 7 days) or severe type 2 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•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-abdominal surgery
•Diabetes mellitus
•Nephropathy with eGFR < 30 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
•Female of child-bearing potential who is pregnant, breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes Intrauterine Device (IUD) og birth control pills.
•Known or suspected hypersensitivity to trial products or related products
•Any condition considered incompatible with participation by the investigators

发起方

Professor, Ph.d. MD. Filip Krag Knop