Topic: Diabetes
Conditions
Interventions
EndoBarrier or Standard Medical Therapy: Subject will be either having the EndoBarrier device or standard medical therapy (medication, diet and exercise) treatment for 12 months followed by another 12
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years (male or female) 2. T2DM for at least 1 year (HbA1c 7.5-10.0% = 58-86 mmol/mol) 3. On oral T2DM medications (metformin is allowed, but not required) 4. BMI 30-50 kg/m2 with adequate insulin reserve as indicated with insulin C-peptide levels > 0.5 ng/mL
Exclusion criteria
Exclusion criteria: 1. Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete questionnaires 2. Non-compliance with eligibility criteria 3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods 4. Current use of insulin 5. Previous diagnosis with Type 1 DM or a history of ketoacidosis 6. Requirement of NSAIDs (non-steroidal anti-inflammatory drugs) or prescription of anticoagulation therapy during the implant period 7. History of iron deficiency and/or iron deficiency anaemia 8. Symptomatic gallstones or kidney stones at the time of screening 9. History of coagulopathy, upper gastro-intestinal bleeding conditions such as oesophageal or gastric varices, congenital or acquired intestinal telangiectasia 10. Previous GI surgery that could affect the ability to place the device or the function of the implant 11. Presence of active H. pylori using C13 urea breath test (if subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enrol into the study) 12. Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder 13. Severe liver (AST, ALT or gGT >4 times upper limit) or kidney failure (serum creatinine >180mmol/l), estimated Glomerular Filtration Rate (GFR) cut-off is 60 14. Severe depression, unstable emotional or psychological characteristics (indicated by Beck Depression Inventory II score >28) 15. Poor dentition and inability to adequately chew food 16. Planned holidays up to three months following the EndoBarrier Implant 17. Previous EndoBarrier implantation 18. Metal implant unsuitable for MRI scanning and claustrophobia as contraindications for MRI scans (sub-group 1 - fMRI study only) 19. Vegetarian, vegan, gluten or lactose intolerance as unsuitable for fMRI food picture paradigm (sub-group 1 fMRI only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; Timepoint(s): 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost-effectiveness of the EndoBarrier device; Timepoint(s): 24 months; 2. HbA1c, Blood pressure, weight loss; Timepoint(s): 12 months 3. Long-term cost-effectiveness of the EndoBarrier device; Timepoint(s): 24 months 4. Mechanism of effect; Timepoint(s): 12 months 5. Safety of the EndoBarrier and frequency of adverse events; Timepoint(s): 24 months | — |
Countries
England, United Kingdom
Contacts
Public ContactNatalia Klimowska-Nassar
Outcome results
None listed