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 ± 18.5 | 116.3 ± 18.2 | 115.7± 22.5 | <0.001 | 0.016 |
| Fat-Mass (kg) | 58.1 ± 12.0 | 55.0 ± 12.5 | 53.3 ± 16.1 | 0.001 | 0.014 |
| HbA1c (mmol/mol) | 61 ± 10 | 56 ± 9 | 55 ± 12 | 0.016 | 0.139 |
| Blood pressure systolic (mmHg) | 143 ± 16 | 129 ± 24 | 125 ± 21 | 0.059 | 0.007 |
| Blood pressure diastolic (mmHg) | 94 ± 10 | 85 ± 15 | 79 ± 16 | 0.107 | 0.021 |
| Glucose infusion rate (mg/kg/min) | 0.50 ± 1.02 | 0.86 ± 0.99 | 0.81 ± 1.28 | <0.001 | 0.034 |
| C-peptide AUC (ng/mL/min) | 8.10 ± 3.01 | 7.27 ± 3.76 | 5.81 ± 2.09 | 0.440 | 0.046 |
| 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 ± 18.5 | 116.3 ± 18.2 | 115.7± 22.5 | <0.001 | 0.016 |
| Fat-Mass (kg) | 58.1 ± 12.0 | 55.0 ± 12.5 | 53.3 ± 16.1 | 0.001 | 0.014 |
| HbA1c (mmol/mol) | 61 ± 10 | 56 ± 9 | 55 ± 12 | 0.016 | 0.139 |
| Blood pressure systolic (mmHg) | 143 ± 16 | 129 ± 24 | 125 ± 21 | 0.059 | 0.007 |
| Blood pressure diastolic (mmHg) | 94 ± 10 | 85 ± 15 | 79 ± 16 | 0.107 | 0.021 |
| Glucose infusion rate (mg/kg/min) | 0.50 ± 1.02 | 0.86 ± 0.99 | 0.81 ± 1.28 | <0.001 | 0.034 |
| C-peptide AUC (ng/mL/min) | 8.10 ± 3.01 | 7.27 ± 3.76 | 5.81 ± 2.09 | 0.440 | 0.046 |
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..
