ISRCTN14102800Active, not recruitingUnknown
Bile acid remediation of diabetes and obesity study
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Imperial College London
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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