Department for Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany.
Obes Surg. 2018 Aug;28(8):2187-2196. doi: 10.1007/s11695-018-3144-9.
A novel-approach for treatment of obesity and diabetes mellitus type 2 (T2DM) is represented by the endoscopic duodenal-jejunal bypass liner (DJBL). Recent data from the German DJBL registry provide evidence for substantial efficacy of the DJBL during the implantation period in obese patients with T2DM. However, little is known about the trends of glycemic control, BMI, and comorbidities after explantation of the DJBL, which have been investigated in the registry in this report.
Patients were selected from the registry if they had a dataset at implantation, explantation, and at least one time point after explantation of the DJBL (n = 77). We also investigated a subgroup of patients with available data at least 1 year (-2 weeks) after explantation of the DJBL (n = 32).
For a mean BMI at implantation and a mean follow-up period, an increase of BMI of 2.1 kg/m (CI 0.8-3.2; p = 0.013) had to be expected (for HbA1c 0.3% (CI - 0.0-0.7; p = n.s.), respectively). In the subgroup analysis, HbA1c and BMI increased after explantation of the DJBL but stayed significantly below baseline levels. Meanwhile, the mean number of antidiabetic drugs slightly increased. There was deterioration seen for blood pressure and LDL cholesterol over the postexplantation period to approximately baseline levels (or higher).
With this data, we show that improvement of HbA1c and BMI can be partly maintained over a time of nearly 1-year postexplantation of the DJBL. However, for HbA1c, this may be biased by intensified medical treatment and effects deteriorated with time after explantation. These results suggest that implantation of the DJBL needs to be integrated in a long-term weight management program as most of other interventions in obese patients with T2DM.
ClinicalTrials.gov Identifier: NCT02731859.
内镜十二指肠空肠旁路管（DJBL）是治疗肥胖和 2 型糖尿病（T2DM）的一种新方法。来自德国 DJBL 注册中心的最新数据为肥胖 T2DM 患者在植入 DJBL 期间的 DJBL 具有显著疗效提供了证据。然而，关于 DJBL 植入后血糖控制、BMI 和合并症的趋势知之甚少，本报告在注册中心对这些内容进行了调查。
如果患者在植入、取出和 DJBL 取出后至少有一个时间点有数据集（n=77），则从注册中心中选择患者。我们还调查了至少在 DJBL 取出后 1 年（-2 周）有可用数据的患者亚组（n=32）。
对于植入时的平均 BMI 和平均随访期，预计 BMI 会增加 2.1kg/m（CI 0.8-3.2；p=0.013）（HbA1c 增加 0.3%（CI -0.0-0.7；p=n.s.））。在亚组分析中，DJBL 取出后 HbA1c 和 BMI 增加，但仍明显低于基线水平。同时，抗糖尿病药物的平均数量略有增加。DJBL 取出后，血压和 LDL 胆固醇的情况恶化，接近基线水平（或更高）。
有了这些数据，我们表明 DJBL 取出后近 1 年的时间内，HbA1c 和 BMI 的改善可以部分维持。然而，对于 HbA1c，这可能会受到强化治疗的影响，并且在 DJBL 取出后随着时间的推移，情况会恶化。这些结果表明，DJBL 的植入需要整合到肥胖 T2DM 患者的长期体重管理计划中，因为这是肥胖 T2DM 患者其他干预措施中大多数的做法。
ClinicalTrials.gov 标识符：NCT02731859。
