The duodenal-jejunal bypass liner (EndoBarrier(R)) for the treatment of type 2 diabetes mellitus in obese patients - efficacy and factors predicting optimal effects
Abstract
Background: The global increase in the incidence of obesity results in an increase in the incidence 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 (DJBL) EndoBarrier(R) (GI Dynamics). is an endoscopic implant that mimics the intestinal bypass portion of the Roux-en-Y gastric bypass. Material and Methods: Twenty patients were included in the study.
They had a mean body mass index (BMI) of 41.9 +- 1.0 kg/sqmand a mean HbA1c concentration of 73.5 +- 4.46 mmol/mol and were receiving T2DM treatment. All patients received complete bariatric support care from a professional team.
The aim of this prospective multi-center study was to determine the effectiveness of the DJBL and to identify clinical factors associated with a better outcome of the DJBL. Results: At 10 months, there was significantly greater weight loss (119.56 +- 3.65 vs. 130.3 +- 3.6 kg; p < 0.05), BMI improvement (38.3 +- 1.01 vs. 41.9 +- 1.0 kg/sqm;p < 0.05), excess weight loss of 23%, and improvement of blood glucose levels (8.5 +- 0.5 vs. 11.9 +- 0.83 mmol; p < 0.05) and long--term diabetes compensation (HbA1c, 56.5 +- 3.28 vs. 73.35 +- 4.46 mmol/mol; p < 0.05).
Mild abdominal pain and nausea were experienced by 72% of patients during the first 14 days after implantation, 33% of patients during the first month, and 10% of patients after one month. Lower initial BMI, distal position of the anchor, and lower body height were identified as prognostic factors for pain.
Conclusion: The DJBL is a safe and effective alternative to surgical bariatric procedures. Lower initial BMI and lower body height could be positive prognostic factors for the superior effect of DJBL treatment.