Trastulli Stefano, Desiderio Jacopo, Grandone Ilenia, Fontana Lucia, Paolini Luisa, Altomare Maria, D'Angelo Paola, Palazzi Mariangela, Cirocchi Roberto, Leotta Sergio, Fatati Giuseppe, Parisi Amilcare
Department of Digestive Surgery and Liver Unit, Santa Maria Hospital, Via Tristano di Joannuccio 1, 05100, Terni, Italy.
Department of Chemistry, Biology and Biotechnology, University of Perugia, Perugia, Italy.
Endocrine. 2017 Mar;55(3):748-753. doi: 10.1007/s12020-016-0996-4. Epub 2016 Jun 3.
No randomized clinical trials (RCTs) have yet evaluated the bariatric surgery's efficacy and safety in patients newly diagnosed with type 2 diabetes mellitus (T2DM). The aim of this multicenter RCT is to compare bariatric surgery, particularly laparoscopic sleeve gastrectomy (LSG), with conventional medical therapy (CMT) in obese patients (body mass index between 30 and 42 kg/m) newly diagnosed with T2DM and without any diabetes-related complications at any stage. A total of 100 eligible patients will be randomized at a 1:1 ratio to undergo one of the two planned treatments and will be followed for at least 6 years after randomization. The main objective of the ESINODOP trial is to investigate the efficacy of LSG compared with CMT alone in inducing and maintaining a remission of T2DM (defined as HbA1c levels ≤6.0 %, without active pharmacologic therapy after 1 year). The remission of T2DM will also be evaluated with the criteria provided by the American Diabetes Association (ADA), and the additional parameters such as adverse event rates, micro- and macrovascular complications, weight loss, gastrointestinal hormones, and quality of life will be compared. The study started on September 2015 and the planned recruitment period is 3 years. Patient recruitment and follow-up take place in the two diabetology and nutrition centers participating in the study, which are performed on a national basis. The ESINODOP trial is designed with the intent of comparing the efficacy of CMT alone to that of CMT in conjunction with LSG performed at the time of diabetes diagnosis in mildly obese diabetic patients. Currently, patients with these characteristics are not eligible for bariatric/metabolic surgery.
尚无随机临床试验（RCT）评估过减肥手术对新诊断出的2型糖尿病（T2DM）患者的疗效和安全性。这项多中心RCT的目的是，在新诊断出T2DM且在任何阶段均无任何糖尿病相关并发症的肥胖患者（体重指数在30至42kg/m之间）中，比较减肥手术，尤其是腹腔镜袖状胃切除术（LSG）与传统药物治疗（CMT）的效果。总共100名符合条件的患者将按1:1的比例随机接受两种计划治疗中的一种，并在随机分组后至少随访6年。ESINODOP试验的主要目的是研究与单纯CMT相比，LSG在诱导和维持T2DM缓解（定义为糖化血红蛋白水平≤6.0%，1年后无需进行积极药物治疗）方面的疗效。还将根据美国糖尿病协会（ADA）提供的标准评估T2DM的缓解情况，并比较不良事件发生率、微血管和大血管并发症、体重减轻、胃肠激素和生活质量等其他参数。该研究于2015年9月开始，计划招募期为3年。患者招募和随访在参与研究的两个糖尿病与营养中心进行，这两个中心在全国范围内开展工作。ESINODOP试验的设计目的是比较单纯CMT与在轻度肥胖糖尿病患者确诊时联合LSG进行CMT的疗效。目前，具有这些特征的患者不符合减肥/代谢手术的条件。
