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十二指肠空肠旁路管 6 个月和 12 个月治疗对肥胖和 2 型糖尿病的影响:一项交叉队列研究。

The Effect of 6 and 12 months Duodenal-Jejunal Bypass Liner Treatment on Obesity and Type 2 Diabetes: a Crossover Cohort Study.

机构信息

Department of General Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.

Department of General Surgery, Rijnstate Medical Center, Arnhem, The Netherlands.

出版信息

Obes Surg. 2018 May;28(5):1255-1262. doi: 10.1007/s11695-017-2997-7.

Abstract

OBJECTIVE

The aim of this research was to study the duodenal-jejunal bypass liner (DJBL) treatment for obesity and type 2 diabetes mellitus (T2DM) in patients after dietary treatment in a cross-over design.

BACKGROUND

DJBL treatment has been proven effective for treatment of obesity and T2DM. However, data on safety and efficacy of a 12-month DJBL treatment is limited.

METHODS

In 2014, our research group reported on a multicenter randomized clinical trial. Patients were randomized to DJBL or dietary treatment (control group). Twenty-eight patients crossed over after their dietary treatment and received up to 12 months of DJBL treatment. Patient visits were conducted at baseline, during DJBL treatment (1 week, 1-6, 9, 12 months) and 6 months after removal of the liner. Patients underwent a standard physical examination, blood sampling, assessment of adverse events, nutritional and diabetes counseling, and a standardized meal tolerance test.

RESULTS

Of the 28 patients included in this study, 24 patients completed 6 months of treatment. Eighteen patients were extended to 12 months of DJBL treatment; 13 patients completed this treatment period. After 6 months of DJBL treatment, a significant increase in excess weight loss (EWL) and decrease in weight, BMI, HbA1c, fasting glucose, cholesterol, HDL and LDL improved significantly. After 12 months of DJBL treatment, these parameters stabilized.

CONCLUSIONS

The DJBL is an effective, minimally invasive treatment option. Even after successful treatment with dietary restrictions, the DJBL is still capable of significantly reducing weight and improving cardiovascular and type 2 diabetes mellitus parameters in obese patients.

摘要

目的

本研究旨在交叉设计中研究十二指肠空肠旁路管(DJBL)治疗饮食治疗后肥胖和 2 型糖尿病(T2DM)患者的效果。

背景

DJBL 治疗已被证明对肥胖和 T2DM 的治疗有效。然而,12 个月 DJBL 治疗的安全性和有效性数据有限。

方法

2014 年,我们的研究小组报告了一项多中心随机临床试验。患者被随机分配到 DJBL 或饮食治疗(对照组)。28 名患者在饮食治疗后交叉接受了长达 12 个月的 DJBL 治疗。患者在基线、DJBL 治疗期间(1 周、1-6 个月、9 个月和 12 个月)以及取出管后 6 个月进行就诊。患者接受标准体检、血液采样、不良事件评估、营养和糖尿病咨询以及标准化餐耐量试验。

结果

在这项研究中,28 名患者中有 24 名完成了 6 个月的治疗。18 名患者延长至 12 个月的 DJBL 治疗;13 名患者完成了该治疗期。DJBL 治疗 6 个月后,超重体重减轻(EWL)和体重、BMI、HbA1c、空腹血糖、胆固醇、HDL 和 LDL 显著降低。12 个月的 DJBL 治疗后,这些参数稳定。

结论

DJBL 是一种有效、微创的治疗选择。即使在成功的饮食限制治疗后,DJBL 仍能显著降低肥胖患者的体重并改善心血管和 2 型糖尿病参数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c711/5968053/5b8345ddb951/11695_2017_2997_Fig1_HTML.jpg

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