Prediabetes and type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
It is known that following weight loss surgery such as roux en y gastric bypass, there is an increase in the delivery of bile acids to the small intestine, with subsequent weight loss/improvement in b
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) 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. 3. Energy expenditure measured using indirect calorimetry before and after the mixed meal tolerance (MMT) test | — |
Countries
England, United Kingdom
Contacts
Public ContactYasmin Tabbakh
Outcome results
None listed