Section of Gastrointestinal Metabolic Surgery, Department of Surgery, Weill Cornell Medical Center, New York Presbyterian Hospital, New York, New York 10065, USA.
Surg Obes Relat Dis. 2012 Jul-Aug;8(4):476-82. doi: 10.1016/j.soard.2012.03.004. Epub 2012 Mar 21.
Data from observational and nonrandomized comparative studies have shown a dramatic effect of bariatric surgery on type 2 diabetes mellitus (T2DM), including in nonobese patients. However, a relative paucity of level 1 evidence is available to define the exact role of surgery as a treatment modality for T2DM, especially in less obese subjects. Performing randomized clinical trials in this field, however, poses significant and specific challenges for the study design. We have addressed such challenges in a carefully designed randomized controlled trial comparing glycemic control with optimal medical management versus Roux-en-Y gastric bypass in overweight to mildly obese patients with T2DM mellitus (body mass index 26-35 kg/m(2)). The present report describes the rationale and design of the Weill Cornell Medical College study. In addition to glycemic endpoints, however, clinical trials should also investigate the effect of surgery on cardiovascular risk or T2DM-specific morbidity. Addressing these endpoints would entail large, randomized clinical trials with prolonged period of observation and ideally a multicenter study design. Such a multisite trial poses substantial logistical and financial challenges, which would predictably delay rather than accelerate progress of research in this field. A consortium of centers performing independent small and medium size randomized clinical trials may provide a more realistic and feasible approach. In this paper, we present an overview of on-going randomized clinical trials in this field and propose a worldwide consortium of randomized controlled trials (WORLDCoRDS) using the Weill Cornell Medical College protocol. The aim of this consortium is to standardize research in T2DM surgery and timely accumulate homogeneous data that can help assess the effects of GI surgery on cardiovascular risk and T2DM-related mortality and morbidity.
来自观察性和非随机对照研究的数据表明，减重手术对 2 型糖尿病（T2DM）具有显著的疗效，甚至对非肥胖患者也是如此。然而，目前可用的一级证据相对较少，无法确定手术作为 T2DM 治疗方法的确切作用，尤其是在体重较轻的患者中。然而，在这一领域开展随机临床试验面临着对研究设计的重大和特殊挑战。我们在一项精心设计的随机对照试验中解决了这些挑战，该试验比较了超重至轻度肥胖的 T2DM 患者（体重指数 26-35kg/m²）接受最佳药物治疗与 Roux-en-Y 胃旁路手术治疗的血糖控制效果。本报告描述了 Weill Cornell 医学院研究的基本原理和设计。然而，除了血糖终点外，临床试验还应研究手术对心血管风险或 T2DM 特异性发病率的影响。要解决这些终点问题，需要进行大型、随机临床试验，观察期较长，理想情况下采用多中心研究设计。这种多中心试验会带来巨大的后勤和财务挑战，预计会延迟而不是加速该领域的研究进展。由多个中心进行独立的小中型随机临床试验的联盟可能提供更现实和可行的方法。本文介绍了该领域正在进行的随机临床试验，并提出了一个全球性的随机对照试验联盟（WORLDCoRDS），采用 Weill Cornell 医学院的方案。该联盟的目的是标准化 T2DM 手术的研究，并及时积累同质数据，以帮助评估胃肠手术对心血管风险和与 T2DM 相关的死亡率和发病率的影响。
