Tu1470 Interim Results of a Multi-Center, Prospective, Controlled Trial of the Duodenal-Jejunal Bypass Liner for the Treatment of Type 2 Diabetes in Obese Patients: Are There Any Factors Predicting a Sub-Optimal Effect?

Abstract

INTRODUCTION: The global increase in obesity incidence results in an increase of type 2 diabetes mellitus (T2DM) incidence. Surgical treatment has proven to be effective, however it carries a high risk of complications. The duodenal-jejunal bypass liner (EndoBarrier®, GI Dynamics, DJBL) is an endoscopic implant that mimics the intestinal bypass portion of the Roux-en-Y Bystric bypass. It results in weight loss and improvements in glucose control in obese patients with T2DM. AIMS & METHODS: This is an interim report of an ongoing three years study. The aim of this prospective, controlled, multicentre study is to determine the effectiveness of DJBL and to identify clinical factors associated with a sub-optimal outcome of DJBL. RESULTS: Forty four subjects (24 with an implant, 20 controls) were included in the study. The groups were comparable with respect to age, gender, BMI (mean 37.7 vs. 38.1 kg/m2), T2DM duration (7.2 vs. 8.3 years), HbA1c level (8.8 % vs 8.1 %) and T2DM treatment. In the DJBL group, all devices were successfully implanted. Only three devices had to be explanted prior to the end of the 6 months study period (bleeding, dislocation and need for ERCP because of choledocholithiasis). The mean procedure time was 21.2 minutes for an implantation and 35.5 minutes for an explantation. At six months there was significantly greater weight loss (27% vs. 9%) and significantly improved HbA1c % (2.3 vs. 1.1) in the DJBL group. T2DMmedicinal treatment could be reduced in more device subjects than controls. There was no serious adverse event. Mild abdominal pain and nausea after implantation were experienced by 75% of patients during first 14 days after implantation, 40% of patients during the first month and 11% of patiens after one month. Lower initial BMI, distal position of the anchor and lower body height were identified as negative prognostic factors for pain. CONCLUSION: The DJBL is safe when implanted for 6 months, and results in significant weight loss and HbA1c reduction. This suggests that this novel device is a candidate for the primary therapy of morbid obesity and type 2 diabetes. Lower initial BMI, distal position of the anchor and lower body height could be negative prognostic factor for pain