PMID- 22551575
OWN - NLM
STAT- MEDLINE
DCOM- 20121126
LR  - 20120730
IS  - 1878-7533 (Electronic)
IS  - 1550-7289 (Linking)
VI  - 8
IP  - 4
DP  - 2012 Jul-Aug
TI  - Medical versus surgical treatment of type 2 diabetes: the search for level 1 
      evidence.
PG  - 476-82
LID - 10.1016/j.soard.2012.03.004 [doi]
AB  - 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.
CI  - Copyright (c) 2012 American Society for Metabolic and Bariatric Surgery. Published 
      by Elsevier Inc. All rights reserved.
FAU - Shukla, Alpana P
AU  - Shukla AP
AD  - Section of Gastrointestinal Metabolic Surgery, Department of Surgery, Weill 
      Cornell Medical Center, New York Presbyterian Hospital, New York, New York 10065, 
      USA.
FAU - Moreira, Marlus
AU  - Moreira M
FAU - Dakin, Greg
AU  - Dakin G
FAU - Pomp, Alfons
AU  - Pomp A
FAU - Brillon, David
AU  - Brillon D
FAU - Sinha, Naina
AU  - Sinha N
FAU - Strain, Gladys W
AU  - Strain GW
FAU - Lebovitz, Harold
AU  - Lebovitz H
FAU - Rubino, Francesco
AU  - Rubino F
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20120321
PL  - United States
TA  - Surg Obes Relat Dis
JT  - Surgery for obesity and related diseases : official journal of the American 
      Society for Bariatric Surgery
JID - 101233161
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - *Bariatric Surgery
MH  - Diabetes Mellitus, Type 2/*drug therapy/*surgery
MH  - Evidence-Based Medicine
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Randomized Controlled Trials as Topic
EDAT- 2012/05/04 06:00
MHDA- 2012/12/10 06:00
CRDT- 2012/05/04 06:00
PHST- 2012/03/13 00:00 [received]
PHST- 2012/03/13 00:00 [accepted]
PHST- 2012/05/04 06:00 [entrez]
PHST- 2012/05/04 06:00 [pubmed]
PHST- 2012/12/10 06:00 [medline]
AID - S1550-7289(12)00093-7 [pii]
AID - 10.1016/j.soard.2012.03.004 [doi]
PST - ppublish
SO  - Surg Obes Relat Dis. 2012 Jul-Aug;8(4):476-82. doi: 10.1016/j.soard.2012.03.004. 
      Epub 2012 Mar 21.