Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-24 @ 1:07 PM
NCT ID:
NCT02459561
Eligibility 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 \> 1665 pmol/L
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 or reliable 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. History or presence of active H. pylori (if subjects are randomised into the EndoBarrier arm and have a history or presence of active H. pylori - tested during study visit 2 - 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02459561
Study Brief:
Protocol Section:
NCT02459561