Does treatment with bile acid tablets improve blood sugar levels and assist in weight loss

Not Applicable

• Conditions: Prediabetes and type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14102800
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-11
• Last Update Posted: 22 January 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut hormone secretion measured using venepuncture following a standardised mixed meal tolerance (MMT) test at -60, 0, 15, 30, 60, 90, 120 and 240 minutes<br>

Secondary Outcome Measures

Name	Time	Method
1. Bodyweight change measured using the TANITA body composition scales at each stud visit (visit 1 at 0 weeks, visit 2 at 3 weeks, visit 3 at 6 weeks and visit 4 at 8 weeks)<br>2. Insulin sensitivity (hepatic and peripheral) measured using the two-step euglycaemic hyperinsulinaemic clamp method. 6, 62H2 glucose isotope will be infused prior to the clamp until a state of equilibrium is reached then the first step of the clamp (hepatic phase) is commenced which lasts 2 hours. The second step is the peripheral phase which also lasts 2 hours. Blood glucose measurements will be taken at 10-minute intervals using a YSI glucose/lactate analyzer alongside samples for glucose and insulin at -120, 0, 30, 60, 90, 100, 110, 120, 150, 180, 210, 220, 230 and 240 minutes. <br>3. Energy expenditure measured using indirect calorimetry before and after the mixed meal tolerance (MMT) test