Betzel Bark, Koehestanie Parviez, Homan Jens, Aarts Edo O, Janssen Ignace M C, de Boer Hans, Wahab Peter J, Groenen Marcel J M, Berends Frits J
Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands.
Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.
Gastrointest Endosc. 2017 Feb;85(2):409-415. doi: 10.1016/j.gie.2016.07.027. Epub 2016 Jul 21.
The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that induces weight loss and improves glycemic control in patients with type 2 diabetes mellitus (T2DM). The aim of the current study was to assess the effects of DJBL explantation on glycemic control and body weight.
This prospective, observational study included only patients with T2DM who had the DJBL implanted for at least 6 months and had a follow-up of at least 12 months after explantation. The primary endpoints were changes in glycosylated hemoglobin A (HbA) and body weight during the 12 months after explantation. Secondary endpoints were changes in fasting plasma glucose, blood pressure, and plasma lipid levels.
In total, 59 patients completed the 12-month follow-up after explantation. During this period body weight increased by 5.6 (standard deviation, 6.4) kg (P < .001) and HbA rose from 65 (SD 17) to 70 (SD 20) mmol/mol (P < .001). However, body weight remained 8.0 (SD 8.6) kg (P < .001) lower than before implantation, that is, corresponding to a net total body weight loss of 7.4% (SD 7.6) (P < .001). Although HbA was significantly higher 12 months after explantation compared with baseline and the mean daily dose of insulin used was comparable, the number of patients on insulin remained significantly lower than before implantation.
Explantation of the DJBL is associated with weight gain and worsening of glycemic control, although some beneficial effects remained detectable 12 months after explantation. A change in strategy is needed to preserve the beneficial effects of DJBL treatment. (Clinical trial registration number: 746∖100111.).
十二指肠-空肠旁路衬管（DJBL）是一种内镜装置，可使2型糖尿病（T2DM）患者体重减轻并改善血糖控制。本研究旨在评估取出DJBL对血糖控制和体重的影响。
这项前瞻性观察性研究仅纳入植入DJBL至少6个月且取出后随访至少12个月的T2DM患者。主要终点是取出后12个月内糖化血红蛋白A（HbA）和体重的变化。次要终点是空腹血糖、血压和血脂水平的变化。
共有59例患者完成了取出后的12个月随访。在此期间，体重增加了5.6（标准差6.4）kg（P <.001），HbA从65（标准差17）升至70（标准差20）mmol/mol（P <.001）。然而，体重仍比植入前低8.0（标准差8.6）kg（P <.001），即总体重净减轻7.4%（标准差7.6）（P <.001）。尽管取出后12个月时HbA显著高于基线，且使用的胰岛素日均剂量相当，但使用胰岛素的患者数量仍显著低于植入前。
取出DJBL与体重增加和血糖控制恶化有关，尽管取出后12个月仍可检测到一些有益效果。需要改变策略以保留DJBL治疗的有益效果。（临床试验注册号：746∖100111。）
