Skip to main content

02-15-2018 | Obesity | Article

EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?

Journal: Obesity Surgery

Authors: Nisha Patel, Aruchuna Mohanaruban, Hutan Ashrafian, Carel Le Roux, James Byrne, John Mason, James Hopkins, Jamie Kelly, Julian Teare

Publisher: Springer US


Background and Aims

Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients.

Materials and Methods

This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30–50 kg/m2 and HbA1c levels of 7.5–10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels.


Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62–29.38; p < 0.05) and BMI (95%CI 1.1–8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1–1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild.


The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.
Control, C. f. D. & Prevention. Prevalence of overweight and obesity among adults with diagnosed diabetes—United States, 1988–1994 and 1999–2002. MMWR. Morbidity and mortality weekly report 53, 1066 (2004).
Hoerger TJ, Segel JE, Gregg EW, et al. Is glycemic control improving in US adults? Diabetes Care. 2008;31(1):81–6. https://​doi.​org/​10.​2337/​dc07-1572. CrossRefPubMed
Sjöström L et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. New England Journal of Medicine. 2004;351:2683–93. https://​doi.​org/​10.​1056/​NEJMoa035622. CrossRefPubMed
Scopinaro N, Marinari GM, Camerini GB, et al. Specific effects of biliopancreatic diversion on the major components of metabolic syndrome a long-term follow-up study. Diabetes Care. 2005;28(10):2406–11. https://​doi.​org/​10.​2337/​diacare.​28.​10.​2406. CrossRefPubMed
Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000;232(4):515–29. https://​doi.​org/​10.​1097/​00000658-200010000-00007. CrossRefPubMedPubMedCentral
Mason EE, Ito C. Gastric bypass in obesity. Surg Clin North Am. 1967;47(6):1345–51. https://​doi.​org/​10.​1016/​S0039-6109(16)38384-0. CrossRefPubMed
Demaria EJ, Jamal MK. Surgical options for obesity. Gastroenterol Clin North Am. 2005;34:127–42. https://​doi.​org/​10.​1016/​j.​gtc.​2004.​12.​005. CrossRefPubMed
Consortium, L. A. o. B. S. Peri-operative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445. CrossRef
Olbers, T. et al. Body composition, dietary intake, and energy expenditure after laparoscopic Roux-en-Y gastric bypass and laparoscopic vertical banded gastroplasty: a randomized clinical trial. Ann Surg 2006; 244, 715–722, doi: https://​doi.​org/​10.​1097/​01.​sla.​0000218085.​25902.​f800000658-200611000-00016.
le Roux CW et al. Gastric bypass reduces fat intake and preference. Am J Physiol. Regulatory, integrative and comparative physiology 301, R1057–1066, doi: https://​doi.​org/​10.​1152/​ajpregu.​00139.​2011 (2011).
Ballesta C, Berindoague R, Cabrera M, et al. Management of anastomotic leaks after laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2008;18(6):623–30. https://​doi.​org/​10.​1007/​s11695-007-9297-6. CrossRefPubMed
Podnos YD, Jimenez JC, Wilson SE, et al. Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg. 2003;138(9):957–61. https://​doi.​org/​10.​1001/​archsurg.​138.​9.​957. CrossRefPubMed
Sugerman HJ, Wolfe LG, Sica DA, et al. Diabetes and hypertension in severe obesity and effects of gastric bypass-induced weight loss. Ann Surg. 2003;237(6):751–8. https://​doi.​org/​10.​1097/​01.​SLA.​0000071560.​76194.​11. CrossRefPubMedPubMedCentral
Gersin KS, Rothstein RI, Rosenthal RJ, et al. Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointest Endosc. 2010;71(6):976–82. https://​doi.​org/​10.​1016/​j.​gie.​2009.​11.​051. CrossRefPubMed
Rodriguez-Grunert L, Galvao Neto MP, Alamo M, et al. First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve. Surg Obes Relat Dis. 2008;4(1):55–9. https://​doi.​org/​10.​1016/​j.​soard.​2007.​07.​012. CrossRefPubMed
Schouten R, Rijs CS, Bouvy ND, et al. A multicenter, randomized efficacy study of the EndoBarrier gastrointestinal liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010;251(2):236–43. https://​doi.​org/​10.​1097/​SLA.​0b013e3181bdfbff​. CrossRefPubMed
Force ABET, Dayyeh BKA, Kumar N, et al. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015;82:425–38. CrossRef
Fox CS, Coady S, Sorlie PD, et al. Increasing cardiovascular disease burden due to diabetes mellitus the Framingham Heart Study. Circulation. 2007;115(12):1544–50. https://​doi.​org/​10.​1161/​CIRCULATIONAHA.​106.​658948. CrossRefPubMed
Group, U. P. D. S. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet. 1998;352:854–65. CrossRef
Points, E. & Group, A. C. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560–72. CrossRef
Gariani K, Mavrakanas T, Combescure C, et al. Is diabetes mellitus a risk factor for venous thromboembolism? A systematic review and meta-analysis of case–control and cohort studies. Eur J Intern Med. 2015;

Novel clinical evidence in continuous glucose monitoring

Novel clinical evidence in continuous glucose monitoring

How real-world studies complement randomized controlled trials

Jean-Pierre Riveline uses data from real-life continuous glucose monitoring studies to illustrate how these can uncover critical information about clinical outcomes that are hard to assess in randomized controlled trials.

This video has been developed through unrestricted educational funding from Abbott Diabetes Care.

Watch the video