The United Kingdom's first NHS EndoBarrier service for long-standing poorly controlled type 2 diabetes and obesity: outcomes one year after EndoBarrier removal

Aims: EndoBarrier is a 60 cm duodenal-jejunal bypass liner endoscopically implanted for up to one year. It mimics the bypass part of Roux-en-Y bariatric surgery and reduces weight and HbA(1c) while it is in situ. We aimed to assess the extent to which these improvements are sustained in people with diabetes in the year following removal. Methods: Between October 2014 and November 2017 we implanted 62 EndoBarriers in an NHS service with all removed by November 2018. Outcomes were monitored in a registry. Results: By November 2019, 46/62 (72%) (mean +/- SD age 51.5 +/- 7.7 years, 52% male, 54.3% white ethnicity, median (IQR) diabetes duration 14.5 (8-20) years, 67.4% insulin-treated and mean +/- SD body mass index (BMI) 41.6 +/- 7.1 kg/m(2)) had attended and 16/62 (28%) did not attend their one-year post-EndoBarrier follow-up appointment. In those who attended, during EndoBarrier implantation mean +/- SD HbA1c fell by 21.1 +/- 19.6 mmol/mol from 77.1 +/- 20.0 to 56.0 +/- 11.2 mmol/mol (p<0.001) (by 1.9 +/- 1.8% from 9.2 +/- 1.8% to 7.3 +/- 1.0% (p<0.001)), weight fell by 17.2 +/- 8.8 kg from 121.9 +/- 29.4 kg to 104.7 +/- 30.1 kg (p<0.001), BMI fell from 41.6 +/- 7.5 to 35.5 +/- 7.5 kg/m(2) (p<0.001), systolic blood pressure from 139.0 +/- 14.0 to 126.0 +/- 14.6 mmHg (p<0.001) and serum alanine aminotransferase from 30.0 +/- 16.9 to 18.8 +/- 11.0 U/L (p<0.001). Median (IQR) total daily insulin dose reduced from 104 (54-162) to 30 (0-62) units (n=31, p<0.001); 10/31 (32%) insulin-treated people with diabetes were able to discontinue insulin. One year post-EndoBarrier, 18/46 (39%) demonstrated fully sustained improvement, 18/46 (39%) partially sustained improvement and 10/46 (22%) reverted to baseline. Of those deteriorating, 9/10 (90%) had depression and/or bereavement; they also had less fall in weight and HbA1c during EndoBarrier treatment. In the 16/62 (28%) who did not attend follow-up, reasons for non-attendance were too far to travel (25%), need to take time off work (6.3%), severe depression (6.3%) and death (6.3%). In 56.3% of cases no reason was given. Conclusion: Our data demonstrate that EndoBarrier is highly effective in people with long-standing poorly controlled type 2 diabetes and obesity, with maintenance of significant improvement one year after removal in 78% of cases for whom data were available. As an endoscopic procedure it is relatively simple and non-invasive and it deserves further investigation.