Medical versus surgical treatment of type 2 diabetes: the search for level 1 evidence.

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.