Abstract
Introduction: The global increase in obesity incidence results in an increase of type 2 diabetes mellitus (T2DM). Surgical treatment has proven to be effective, however it carries a high risk of complications. The duodenal-jejunal bypass liner (EndoBarrier®, GI Dynamics, EB) is an endoscopic implant that mimics the intestinal bypass portion of the Roux-en-Y Gastric Bypass. It results in weight loss and improvements in glucose control in obese patients with T2 diabetes mellitus (T2DM). Aims and Methods: This is a analysis of a prospective, controlled, multicentre study aimed to identify factors associated with an outcome of EB for T2DM. Results: Seventy subjects (45 with an implant, 25 controls) were included in the study. The groups were comparable with respect to age, gender, BMI (mean 41.7 vs. 39.5 kg/m2), T2DM duration (7.8 vs. 8.3 years), HbA1c level (88 vs. 86 mmol/mol) and T2DM treatment. In the EB group, all devices were successfully implanted. Only 6 devices had to be explanted prior to the end of the 10 months study period (bleeding, dislocation and need for ERCP because of choledocholithiasis). At 10 months there was significantly greater weight loss and %EWL (19% vs. 7% and 43 vs. 12) and significantly improved long term compensation of T2DM marker HbA1c (decreased by 25 vs. 10 mmol/mol) in the EB group. T2DM medicinal treatment could be reduced in more device subjects than controls. There was no serious adverse event. Deepness of anchor ingrow, lower initial BMI and lower body height were identified as positive factors for efficacy of EB for T2DM compensation. Conclusion: The EB is safe when implanted for 10 months, and results in significant weight loss and HbA1c reduction. Deepness of anchor ingrow, lower initial BMI and lower body height could be positive factors for efficacy. Disclosure M. Benes: None. P. Drastich: None. T. Hucl: None.
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