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Year: 2012 Volume: 8 Issue: 3

Year: 2012 Volume: 8 Issue: 2

Year: 2012 Volume: 8 Issue: 1

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

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Shukla, Alpana P. Moreira, Marlus Dakin, Greg Pomp, Alfons Brillon, David Sinha, Naina Strain, Gladys W. Lebovitz, Harold Rubino, Francesco
Description	Country affiliation: United States Author Affiliation: Shukla AP ( Section of Gastrointestinal Metabolic Surgery, Department of Surgery, Weill Cornell Medical Center, New York Presbyterian Hospital, New York, New York 10065, USA.)
Abstract	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.
File Format	HTM / HTML
ISSN	15507289
Issue Number	4
Volume Number	8
e-ISSN	18787533
Journal	Surgery for Obesity and Related Diseases
Language	English
Publisher	Elsevier
Publisher Date	2012-07-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Metabolism Discipline General Surgery Bariatric Surgery Diabetes Mellitus, Type 2 Drug Therapy Surgery Hypoglycemic Agents Therapeutic Use Evidence-based Medicine Humans Randomized Controlled Trials As Topic Comparative Study Journal Article Research Support, Non-u.s. Gov't Review
Content Type	Text
Resource Type	Article
Subject	Surgery

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