PMID- 35879015
OWN - NLM
STAT- MEDLINE
DCOM- 20220727
LR  - 20221207
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 12
IP  - 7
DP  - 2022 Jul 25
TI  - Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) 
      study: rationale and design of a randomised controlled study.
PG  - e054313
LID - 10.1136/bmjopen-2021-054313 [doi]
LID - e054313
AB  - INTRODUCTION: Bariatric surgery is an effective method of controlling glycaemia 
      in patients with type 2 diabetes mellitus (T2DM) and obesity. Long-term studies 
      suggest that although glycaemic control remains good, only 20%-40% of patients 
      will maintain remission according to the American Diabetes Association criteria. 
      PURPOSE: This trial aims to examine the safety and efficacy of combining 
      Roux-en-Y gastric bypass or sleeve gastrectomy with goal-directed medical therapy 
      to improve long-term glycaemic control of T2DM. METHODS AND ANALYSIS: This 
      prospective, open-label multicentre randomised controlled trial (RCT) will 
      recruit 150 patients with obesity and T2DM from tertiary care obesity centres. 
      Patients will be randomised 1:1 to receive either bariatric surgery and standard 
      medical care or bariatric surgery and intensive goal-directed medical therapy, 
      titrated to specific targets for glycated haemoglobin (HbA1c), blood pressure 
      (BP) and low-density lipoproteins (LDL) cholesterol. The primary endpoints are 
      the proportion of patients in each arm with an HbA1c<6.5% (48 mmol/mol) at 1 year 
      and the proportion of patients in each arm achieving the composite endpoint of 
      HbA1c<6.5% (48 mmol/mol), BP<130/80 mm Hg and LDL<2.6 mmol/L at 5 years. ETHICS 
      AND DISSEMINATION: The local institutional review board approved this study. This 
      study represents the first RCT to examine the safety and efficacy of combining 
      bariatric surgery with intensive medical therapy compared with bariatric surgery 
      and usual care for long-term diabetes control. TRIAL REGISTRATION NUMBER: 
      NCT04432025.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Sudlow, Alexis
AU  - Sudlow A
AUID- ORCID: 0000-0002-9040-0803
AD  - Department of Upper GI and Bariatric Surgery, Southmead Hospital, Bristol, UK 
      asudlow@gmail.com.
FAU - Miras, Alexander Dimitri
AU  - Miras AD
AD  - School of Medicine, Ulster University, Londonderry, UK.
AD  - Department of Metaolism, Digestion and Reproduction, Imperial College London, 
      London, UK.
FAU - Cohen, Ricardo Vitor
AU  - Cohen RV
AUID- ORCID: 0000-0001-8779-3055
AD  - The Center for Obesity and Diabetes, Hospital Alemao Oswaldo Cruz, Sao Paulo, 
      Brazil.
AD  - Health Research Unit, Hospital Alemao Oswaldo Cruz, Sao Paulo, Brazil.
FAU - Kahal, Hassan
AU  - Kahal H
AD  - Department of Diabetes and Endocrinology, Southmead Hospital, Bristol, UK.
FAU - Townley, Jill
AU  - Townley J
AD  - Department of Surgery, Southmead Hospital, Bristol, UK.
FAU - Heneghan, Helen
AU  - Heneghan H
AD  - Department of Surgery, St Vincent's University Hospital, Dublin, Ireland.
FAU - Le Roux, Carel
AU  - Le Roux C
AD  - Department of Experimental Pathology, University College Dublin, Dublin, Ireland.
FAU - Pournaras, Dimitri J
AU  - Pournaras DJ
AD  - Department of Upper GI and Bariatric Surgery, Southmead Hospital, Bristol, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT04432025
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220725
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Glycated Hemoglobin A)
SB  - IM
MH  - *Bariatric Surgery/methods
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy/surgery
MH  - *Gastric Bypass/methods
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Obesity/complications/surgery
MH  - *Obesity, Morbid/surgery
MH  - Treatment Outcome
PMC - PMC9328090
OTO - NOTNLM
OT  - DIABETES & ENDOCRINOLOGY
OT  - General diabetes
OT  - SURGERY
COIS- Competing interests: RVC has received an honorarium as a member of the Speaker's 
      panel of Johnson & Johnson. CLR has received grants from the Science Foundation 
      Ireland, Health Research Board, Irish Research Council, Johnson & Johnson and 
      AnaBio. Personal fees have been received from Eli Lily, Johnson & Johnson, Sanofi 
      Aventis, Astra Zeneca, Janssen, Bristol-Meyers Squibb and Boehringer-Ingelheim. 
      He is on the advisory board for GI dynamics. DJP has received personal fees from 
      NovoNordisk and Johnson & Johnson.
EDAT- 2022/07/26 06:00
MHDA- 2022/07/28 06:00
PMCR- 2022/07/25
CRDT- 2022/07/25 21:12
PHST- 2022/07/25 21:12 [entrez]
PHST- 2022/07/26 06:00 [pubmed]
PHST- 2022/07/28 06:00 [medline]
PHST- 2022/07/25 00:00 [pmc-release]
AID - bmjopen-2021-054313 [pii]
AID - 10.1136/bmjopen-2021-054313 [doi]
PST - epublish
SO  - BMJ Open. 2022 Jul 25;12(7):e054313. doi: 10.1136/bmjopen-2021-054313.