Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University Hospital of Freiburg, Freiburg, Germany.
Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Diabetes Obes Metab. 2018 Aug;20(8):1868-1877. doi: 10.1111/dom.13300. Epub 2018 Apr 23.
The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs.
To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients.
Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m vs -0.39 kg/m ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better.
This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.
十二指肠空肠旁路管（DJBL）是一种模拟手术性十二指肠空肠旁路的内镜装置，用于治疗与肥胖相关的 2 型糖尿病。本分析旨在评估 DJBL 与生活方式改变和抗糖尿病药物相比的疗效和安全性。
为了确定 DJBL 的疗效和长期安全性，分析了来自德国 DJBL 注册中心的 235 例肥胖 2 型糖尿病患者的数据。为了与标准治疗进行比较，应用倾向评分匹配，将患者与德国 DPV 注册中心的患者进行匹配，包括性别、年龄、糖尿病病程、基线 BMI 和基线 HbA1c 等匹配参数。最终匹配队列包括 DJBL 组的 111 例患者和 222 例匹配的对照 DPV 患者。
DJBL 的平均治疗时间为 47.5±12.2 周，平均 BMI 降低 5.0kg/m（P<0.001），HbA1c 降低 1.3%（11.9mmol/mol）（P<0.001）。观察到抗糖尿病药物的减少以及其他代谢和心血管风险参数的改善。与匹配的对照组相比，HbA1c（-1.37%比-0.51%[12.6 比 3.2mmol/mol]；P<0.0001）和 BMI（-3.02kg/m 比-0.39kg/m；P<0.0001）的平均降低幅度明显更高。总胆固醇、LDL 胆固醇和血压也明显更好。
这项研究提供了迄今为止最大的、产生假说的证据，证明 DJBL 作为肥胖 2 型糖尿病患者的替代治疗选择，可能具有积极的风险/获益比。
