Endobarrier (R) Gastrointestinal Liner In Obese Subjects With Type 2 Diabetes-Short- And Midterm Effects On Glucose Metabolism

Background: A 60cm endoscopically implantable, duodeno-jejunal bypass liner (Endobarrier®) has been introduced as a therapeutic option for obese subjects with type 2 diabetes (T2DM). The aim of the study was to explore short and mid-term metabolic effects in the clamp setting. Materials and Methods: This open, single-center trial investigated 10 obese, T2DM subjects with suboptimal glycemic control (HbA1c >48mmol/mol). Prior to the implantation of the gastrointestinal liner (baseline), 4 weeks and 9 months (explantation) after, all subjects underwent Dual-energy X-ray absorptiometry (DXA) measurement, assessment of beta cell function and insulin sensitivity by a Botnia clamp procedure and a mixed-meal tolerance test. Results: We investigated 10 patients with a mean age of 48±9 years and mean diabetes duration of 7±6 years. Detailed results and changes over the time are given in Table. No device has been removed prematurely. Conclusion: Treating obese T2DM subjects by an endoluminally implanted Endobarrier® leads to moderate weight reduction with large inter-individual variation. Significant improvements in insulin sensitivity occurred already 4 weeks after the Endobarrier® implantation, which were maintained until the explantation of the device, accompanied by reductions in blood pressure.Baseline (mean±SD)4 Weeks (mean±SD)9 Monhts (mean±SD)p-value (Group comparison baseline vs. 4 weeks)p-value (Group comparison baseline vs. 9 months)Body weight (kg)121.2 ± 18.5116.3 ± 18.2115.7± 22.5<0.0010.016Fat-Mass (kg)58.1 ± 12.055.0 ± 12.553.3 ± 16.10.0010.014HbA1c (mmol/mol)61 ± 1056 ± 955 ± 120.0160.139Blood pressure systolic (mmHg)143 ± 16129 ± 24125 ± 210.0590.007Blood pressure diastolic (mmHg)94 ± 1085 ± 1579 ± 160.1070.021Glucose infusion rate (mg/kg/min)0.50 ± 1.020.86 ± 0.990.81 ± 1.28<0.0010.034C-peptide AUC (ng/mL/min)8.10 ± 3.017.27 ± 3.765.81 ± 2.090.4400.046 Disclosure N.J. Tripolt: None. F. Aberer: None. J. Url: None. P.N. Pferschy: None. C. Högenauer: None. F. Schreiber: None. A. Eherer: None. E. Svehlikova: None. C. Sourij: None. A.M. Obermayer: None. V. Stadlbauer: None. H. Sourij: Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Novo Nordisk A/S, Amgen Inc., Sanofi, MSD K.K.. Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH, MSD K.K., GI Dynamics Inc..