Aims: EndoBarrier, a 60cm proximal intestinal liner, endoscopically implanted for up to one-year, reduces weight and HbA1c. As the risk of progressive chronic kidney disease (CKD) is increased by high BMI, we assessed the impact of EndoBarrier on renal function. Methods: Between October 2014 and November 2017 we implanted EndoBarriers in 62 patients with sub-optimally controlled diabesity in our NHS service; by November 2018 all were explanted. Clinical and laboratory outcomes, including routinely performed kidney function testing by serum creatinine and MDRD eGFR, were collected in a registry Results: In 61 patients (aged 51.4±7.2 years, 54.1% male, 57.4% europid, diabetes duration 12.0 (8.0-19.5) years, 57.4% insulin-treated, BMI 41.9±7.4 kg/m2) with implant and explant data, weight fell by 15.9±8.5 kg from 122.6±27.9 to 106.7±28.9 kg (p<0.001), BMI from 41.9±7.4 to 36.2±7.6 kg/m2 (p<0.001) and systolic blood pressure (BP) from 138.5±15.0 to 125.8±14.6 mmHg (p<0.001), mean±SD. HbA1c fell by 23.7±21.4 mmol/mol from 80.2±22.5 to 56.5±11.5 mmol/mol(p<0.001), cholesterol from 4.7±1.4 to 3.9±0.9 mmol/L (p<0.001) and alanine-aminotransferase (ALT – a marker of liver fat) from 33.2±19.8 to 19.5±11.4 U/L (p<0.001). In the 35 insulin-treated patients median (IQR) insulin dose reduced from 100 (54-140) to 40 (0-70) units (p<0.001) with 10/35 (28.6%) discontinuing insulin. With regard to renal function, mean±SD serum creatinine improved by 5.5±15.4 μmol/L from 91.7±47.7 to 86.2±45.7 μmol/L (p=0.007) and estimated-Glomerular-Filtration-Rate (abbreviated MDRD equation) improved by 5.8±10.7 ml/min/1.73m2 from 84.3±25.2 to 90.1±26.4 ml/min/1.73m2 (p<0.001). Five patients had raised serum creatinine (>133 μmol/L) prior to Endobarrier; after implantation in four of these creatinine reduced and in two normalised. The four patients with renal impairment who sustained improvement had large weight loss (19.3-34.4 kg), the patient without improvement had only 6.6 kg weight loss. Conclusion: As well as previously documented improvements in weight, HbA1c, BP, ALT and cholesterol, EndoBarrier was associated with improvements in renal function. These observational findings warrant further investigation through prospective study of the impact of such bariatric interventions on progressive CKD.

Aims: EndoBarrier is a 60cm duodenal-jejunal bypass liner endoscopically implanted for up to one year and designed to mimic the by-pass part of Roux-en-Y bariatric surgery. We aimed to assess the safety and efficacy of EndoBarrier in patients with suboptimally-controlled diabesity.Methods: Between July 2013 and November 2017 we implanted 90 EndoBarriers in a single centre with all removed by November 2018. Outcomes were monitored in a registry.Results: All 90 patients have completed one-year post EndoBarrier removal and, of these, 71/90 (79%) -age 51.3±8.6 years, 46% male, 52% White ethnicity, diabetes duration 13.0 (7.0-17.0) years, 59% insulin-treated, BMI 41.1±6.5kg/m 2 ) -attended follow-up and 19/90 (21%) did not attend follow-up. During EndoBarrier implantation, mean±SD HbA1c fell by 19.5±18.4mmol/mol from 78.1±18.9 to 58.6±13.6mmol/mol (p<0.001), weight by 15.9±8.6kg from 118.4±27.0 to 102.4±27.7kg (p<0.001), systolic BP from 139.0±15.0mmHg to 126.6±17.6mmHg (p<0.001), cholesterol from 4.8±1.2 to 4.0±1.0mmol/L (p<0.001), and serum alanine-aminotransferase (marker of liver fat) from 31.0±16.5 to 19.8±11.5U/L (p<0.001). Median (IQR) total daily insulin dose reduced from 98 (53-163) to 30 (0-63 ) units (p<0.001). Eleven of 42 (26.2%) insulin treated patients discontinued insulin. One year post-EndoBarrier 32/71 (45%) demonstrated fully-sustained improvement, 25/71 (35%) partially-sustained improvement and 14/71 (20%) reverted to baseline. Of those deteriorating, 10/14 (71%) had depression and/or bereavement. Thirteen of 90 (14%) patients required early EndoBarrier removal: five for gastrointestinal haemorrhage, two for liver abscess, one for non-hepatic intra-abdominal abscess, and five for gastrointestinal symptoms. All made a full recovery.Conclusion: Our data demonstrate EndoBarrier as highly effective in patients with refractory diabesity, with maintenance of significant improvement one year after removal in 80% of cases. As it requires only an endoscopic procedure, EndoBarrier treatment is relatively simple and non-invasive and it deserves further investigation.