Exp Clin Endocrinol Diabetes 2014; 122 - P104
DOI: 10.1055/s-0034-1372121

Implantation of an endoscopically deployed duodenal-jejunal bypass Liner (DJBL) in obese type 2 diabetes subjects – 12 months follow up of eight subjects

B Stratmann 1, Y Krepak 1, M Hauber 1, YH Lee-Barkey 1, M Fischer 1, T Diethelm 1
  • 1Herz und Diabeteszentrum NRW, Diabeteszentrum, Bad Oeynhausen, Germany

Evaluation of treatment of obese type 2 diabetes (T2DM) subjects with DJBL (EndoBarrier®), a 60-cm, impermeable polymer liner anchored in the duodenum to create a duodenal-jejunal bypass.

10 subjects with T2DM (3F, 7 M; age 55.5yrs (IQR 44.0 – 59.5); T2DM duration 8.0yrs (IQR 6.5 – 11.3); BMI 47.1 kg/m2 (IQR 40.6 – 53.8)) were followed 12 month after implantation (IM) until explantation (12 M).

Implantation procedures were without complications, abdominal pain and nausea were commonly described side effects following IM. Antidiabetic medication was reduced upon IM, HbA1c level remained constant (IM: 7.65%; 12 M: 7.55%). BMI was lowered significantly (-2.2 kg/m2), patients lost fat mass and gained equal amounts of lean mass. Cholesterol did not change significantly, but liver parameters improved significantly until 8 months follow up.

Standardized mixed-meal-tolerance tests (500 kcal) were performed regularly in 8 patients and data were analyzed regarding GLP-1, Leptin and Ghrelin. Area under the curve analysis was performed and results were compared by repeated measurement ANOVA. Regarding GLP-1 an increase was detectable in the cohort after implantation which was not statistically significant: IM: 293 pmol/l (IQR 170 – 326); 12 M: 414 pmol/l (IQR 276 – 519). Leptin levels decreased significantly (p < 0.05) after 1 week and reached pretreatment levels after 8 M; IM: 1.9 µg/ml (IQR 1.5 – 6.3), 1W: 1.2 µg/ml (IQR 0.7 – 4.6). Ghrelin levels increased non-significantly after implantation and decreased during follow up: IM: 59.7 ng/ml (IQR 51.4 – 91.2), 1W: 65.8 ng/ml (IQR 52.2 – 124.0), 61.2 ng/ml (IQR 56.6 – 67.2), 12 M: 44.4 ng/ml (IQR 24.2 – 56.9).

The DJBL improves status in obese subjects with T2DM and therefore represents a non-surgical, reversible alternative to bariatric surgery. However, response to the device with regard to weight loss and improvement in diabetes is highly individual. Information from trials including more patients is needed to evaluate the effects in more detail.