Kenngott Hannes G, Clemens Gabriella, Gondan Matthias, Senft Jonas, Diener Markus K, Rudofsky Gottfried, Nawroth Peter P, Büchler Markus W, Fischer Lars, Müller-Stich Beat P
Trials. 2013 Jun 20;14:183. doi: 10.1186/1745-6215-14-183.
Type 2 diabetes mellitus (T2DM) is a disease with high prevalence, associated with severe co-morbidities as well as being a huge burden on public health. It is known that glycemic control decreases long-term morbidity and mortality. The current standard therapy for T2DM is medical treatment. Several randomized controlled trials (RCTs) performed in obese patients showed remission of T2DM after bariatric surgery. Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese, insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM. This study aims at investigating whether Roux-en-Y gastric bypass (RYGB) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality.
The DiaSurg 2 trial is a multicenter, open randomized controlled trial comparing RYGB including standardized medical treatment if needed to exclusive standardized medical treatment of T2DM (control group). The primary endpoint is a composite time-to-event endpoint (cardiovascular death, myocardial infarction, coronary bypass, percutaneous coronary intervention, non-fatal stroke, amputation, surgery for peripheral atherosclerotic artery disease), with a follow-up period of 8 years. Insulin-dependent T2DM patients aged between 30 and 65 years will be included and randomly assigned to one of the two groups. The experimental group will receive RYGB and, if needed, standardized medical care, whereas the control group will receive exclusive standardized medical care, both according to the national treatment guidelines for T2DM. Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population. Assuming a loss to follow-up rate of 20%, 200 patients will be randomly allocated to the comparison groups. A total sample size of n=400 is sufficient to ensure 80% power in a two-tailed significance test at alpha=5%.
The DiaSurg2 trial will yield long-term data (8 years) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or standardized medical care.
The trial protocol has been registered in the German Clinical Trials Register DRKS00004550.
2型糖尿病（T2DM）是一种高患病率疾病，与严重的合并症相关，也是公共卫生的巨大负担。已知血糖控制可降低长期发病率和死亡率。T2DM的当前标准治疗是药物治疗。在肥胖患者中进行的几项随机对照试验（RCT）显示，减重手术后T2DM得到缓解。最近的RCT表明，减重手术在非病态和非重度肥胖的胰岛素依赖型T2DM患者中产生类似效果，这表明目前用于减重手术的方法可作为T2DM患者的新治疗方法。本研究旨在调查Roux-en-Y胃旁路术（RYGB）在预防非重度肥胖T2DM患者的长期并发症和死亡率方面是否为一种有效治疗方法。
DiaSurg 2试验是一项多中心、开放随机对照试验，比较RYGB（必要时包括标准化药物治疗）与单纯T2DM标准化药物治疗（对照组）。主要终点是复合事件发生时间终点（心血管死亡、心肌梗死、冠状动脉搭桥、经皮冠状动脉介入治疗、非致命性中风、截肢、外周动脉粥样硬化疾病手术），随访期为8年。年龄在30至65岁之间的胰岛素依赖型T2DM患者将被纳入并随机分配到两组之一。实验组将接受RYGB治疗，必要时接受标准化医疗护理，而对照组将仅接受标准化医疗护理，均按照T2DM的国家治疗指南进行。统计分析基于意向性治疗人群的Cox比例风险回归。假设失访率为20%，将有200名患者随机分配到比较组。总样本量n = 400足以在α = 5%的双侧显著性检验中确保80%的检验效能。
DiaSurg2试验将产生关于接受RYGB或标准化医疗护理的胰岛素依赖型T2DM患者糖尿病相关发病率和死亡率的长期数据（8年）。
该试验方案已在德国临床试验注册中心DRKS00004550注册。
