Diabetes Research Division, Department of Medicine, Copenhagen University Hospital Gentofte, Hellerup, Denmark.
BMJ Open. 2013 Sep 13;3(9):e003417. doi: 10.1136/bmjopen-2013-003417.
Obese patients with type 2 diabetes undergoing bariatric surgery experience significant and lasting weight loss and improved glycaemic control. However, bariatric surgical procedures such as Roux-en-Y gastric bypass are irreversible and associated with considerable short-term and long-term risks. The EndoBarrier Gastrointestinal Liner or duodenal-jejunal bypass sleeve (DJBS) is a fully reversible procedure that has been developed to treat obesity and type 2 diabetes. We aim to perform a systematic review and meta-analysis of safety and efficacy of DJBS.
A systematic review with meta-analysis (as per the preferred reporting items for systematic reviews and meta-analyses) of randomised controlled trials of the device (vs no intervention, sham and/or low-calorie diet) will be performed. Primary endpoints include change in body weight and glycated haemoglobin and safety. Secondary endpoints constitute changes in other glycaemic parameters and blood lipids and the proportion of patients discontinuing antidiabetic medication. MEDLINE, EMBASE, The Cochrane Library and Science Citation Index will be sought electronically along with manual searches. The primary meta-analysis will use random effects models due to an expected intertrial heterogeneity. Fixed effect meta-analysis will be executed to assess the impact of small trials. Dichotomous data will be analysed using risk difference and continuous data using weighted mean differences, both with 95% CIs.
The study will describe the impact of DJBS on obesity and type 2 diabetes and possibly contribute to clinical decision-making. The results of this study will be disseminated by peer-reviewed publication and scientific presentations.
PROSPERO CRD42013004819.
患有 2 型糖尿病的肥胖患者接受减重手术可显著且持久地减轻体重并改善血糖控制。然而，Roux-en-Y 胃旁路等减重手术是不可逆的，并伴有相当大的短期和长期风险。EndoBarrier 胃肠道覆膜或十二指肠空肠旁路袖套（DJBS）是一种完全可逆的手术，旨在治疗肥胖症和 2 型糖尿病。我们旨在对 DJBS 的安全性和有效性进行系统评价和荟萃分析。
将对该设备（与无干预、假手术和/或低热量饮食相比）的随机对照试验进行系统评价和荟萃分析（按照系统评价和荟萃分析的首选报告项目进行）。主要终点包括体重和糖化血红蛋白的变化以及安全性。次要终点包括其他血糖参数和血脂的变化以及停止使用抗糖尿病药物的患者比例。将通过电子方式搜索 MEDLINE、EMBASE、Cochrane 图书馆和科学引文索引，并进行手动搜索。由于预期存在试验间异质性，主要荟萃分析将使用随机效应模型。将执行固定效应荟萃分析以评估小试验的影响。二分类数据将使用风险差异进行分析，连续数据将使用加权均数差进行分析，均采用 95%置信区间。
该研究将描述 DJBS 对肥胖症和 2 型糖尿病的影响，并可能有助于临床决策。该研究的结果将通过同行评审的出版物和科学演讲进行传播。
PROSPERO CRD42013004819。
