Bile acid remediation of diabetes and obesity study

Imperial College London0 个研究点目标入组 36 人开始时间: 2023年9月11日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•1. Aged between 18-80 years old
•2. BMI =22 kg/m2
•3. Diagnosed with type two diabetes mellitus (T2DM) according to WHO 2006 10 and WHO 201111 criteria =6 months but less than 10 years
•4. HbA1c =42 mmol/mol and =75 mmol/mol
•5. If there are concerns about the stability of glycaemic control then two measurements of HbA1c varying by no more than ±11 mmol/mol on two measurements separated by at least 30 days will be done. If no concerns regarding stability then this does not need to be done
•6. T2DM treated with either lifestyle measures, monotherapy with metformin, sulphonylurea, sodium-glucose co-transporter-2 (SGLT-2) inhibitor, or dipeptidyl
•peptidase-4 (DPP-IV) inhibitor
•7. Liver function tests up to 1.5x the upper limit of normal

•1. Unable to give informed consent
•2. Hepatobiliary, gastrointestinal or other diseases which in the opinion of the study investigators will compromise participant safety or the scientific value of data obtained
•3. Functional diarrhoea with stool frequency =5 times a day
•4. Current treatment with GLP-1 analogues or insulin
•5. Sensitivity to CDCA or UDCA in the past
•6. Current pregnancy (women with childbearing potential will be asked to use high-reliability methods of contraception during the study)
•7. Alcohol in excess of NHS recommended weekly allowance or substance misuse
•8. Previous gut resection which in the opinion of the PI will affect the results of the study

发起方