PMID- 34647708
OWN - NLM
STAT- MEDLINE
DCOM- 20220217
LR  - 20230923
IS  - 1528-1140 (Electronic)
IS  - 0003-4932 (Print)
IS  - 0003-4932 (Linking)
VI  - 275
IP  - 3
DP  - 2022 Mar 1
TI  - Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and 
      Obesity: A Multicenter Randomized Controlled Trial.
PG  - 440-447
LID - 10.1097/SLA.0000000000004980 [doi]
AB  - OBJECTIVE: The aim of this study was to examine the clinical efficacy and safety 
      of the duodenal-jejunal bypass liner (DJBL) while in situ for 12 months and for 
      12 months after explantation. SUMMARY BACKGROUND DATA: This is the largest 
      randomized controlled trial (RCT) of the DJBL, a medical device used for the 
      treatment of people with type 2 diabetes mellitus (T2DM) and obesity. Endoscopic 
      interventions have been developed as potential alternatives to those not eligible 
      or fearful of the risks of metabolic surgery. METHODS: In this multicenter 
      open-label RCT, 170 adults with inadequately controlled T2DM and obesity were 
      randomized to intensive medical care with or without the DJBL. Primary outcome 
      was the percentage of participants achieving a glycated hemoglobin reduction of 
      >/=20% at 12 months. Secondary outcomes included weight loss and cardiometabolic 
      risk factors at 12 and 24 months. RESULTS: There were no significant differences 
      in the percentage of patients achieving the primary outcome between both groups 
      at 12 months [DJBL 54.6% (n = 30) vs control 55.2% (n = 32); odds ratio (OR) 
      0.93, 95% confidence interval (CI): 0.44-2.0; P = 0.85]. Twenty-four percent (n = 
      16) patients achieved >/=15% weight loss in the DJBL group compared to 4% (n = 2) 
      in the controls at 12 months (OR 8.3, 95% CI: 1.8-39; P = .007). The DJBL group 
      experienced superior reductions in systolic blood pressure, serum cholesterol, 
      and alanine transaminase at 12 months. There were more adverse events in the DJBL 
      group. CONCLUSIONS: The addition of the DJBL to intensive medical care was 
      associated with superior weight loss, improvements in cardiometabolic risk 
      factors, and fatty liver disease markers, but not glycemia, only while the device 
      was in situ. The benefits of the devices need to be balanced against the higher 
      rate of adverse events when making clinical decisions. TRIAL REGISTRATION: 
      ISRCTN30845205. isrctn.org; Efficacy and Mechanism Evaluation Programme, a 
      Medical Research Council and National Institute for Health Research (NIHR) 
      partnership reference 12/10/04.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Ruban, Aruchuna
AU  - Ruban A
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
FAU - Miras, Alexander D
AU  - Miras AD
AD  - Department of Metabolism, Digestion and Reproduction, Imperial College, London, 
      UK.
FAU - Glaysher, Michael A
AU  - Glaysher MA
AD  - Division of Surgery, University Hospital Southampton NHS Foundation Trust, 
      Southampton, UK.
FAU - Goldstone, Anthony P
AU  - Goldstone AP
AD  - PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, 
      Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging 
      Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith 
      Hospital, London, UK.
FAU - Prechtl, Christina G
AU  - Prechtl CG
AD  - Imperial College London, Department of Public Health, Imperial Clinical Trials 
      Unit, London, UK.
FAU - Johnson, Nicholas
AU  - Johnson N
AD  - Imperial College London, Department of Public Health, Imperial Clinical Trials 
      Unit, London, UK.
FAU - Chhina, Navpreet
AU  - Chhina N
AD  - PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, 
      Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging 
      Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith 
      Hospital, London, UK.
FAU - Al-Najim, Werd
AU  - Al-Najim W
AD  - Diabetes Complications Research Center, University College Dublin, Ireland.
FAU - Aldhwayan, Madhawi
AU  - Aldhwayan M
AD  - Department of Community Health Sciences, College of Applied Medical Sciences, 
      King Saud University, Riyadh, Saudi Arabia.
FAU - Klimowska-Nassar, Natalia
AU  - Klimowska-Nassar N
AD  - Imperial College London, Department of Public Health, Imperial Clinical Trials 
      Unit, London, UK.
FAU - Smith, Claire
AU  - Smith C
AD  - Imperial College London, Department of Public Health, Imperial Clinical Trials 
      Unit, London, UK.
FAU - Lord, Joanne
AU  - Lord J
AD  - Southampton Health Technology Assessment Center, University of Southampton, 
      Southampton, UK.
FAU - Li, Jia V
AU  - Li JV
AD  - Section of Nutritional research, Department of Metabolism, Digestion and 
      Reproduction, Imperial College London, UK.
FAU - Flores, Lilliam
AU  - Flores L
AD  - PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, 
      Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging 
      Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith 
      Hospital, London, UK.
FAU - Al-Lababidi, Moaz
AU  - Al-Lababidi M
AD  - PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, 
      Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging 
      Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith 
      Hospital, London, UK.
FAU - Dimitriadis, Georgios K
AU  - Dimitriadis GK
AD  - Department of Endocrinology, King's College Hospital NHS Trust, London, UK.
FAU - Patel, Mayank
AU  - Patel M
AD  - University Hospital Southampton NHS Foundation Trust, Biomedical Research Center, 
      Southampton, UK.
FAU - Moore, Michael
AU  - Moore M
AD  - Primary Care, Population Sciences and Medical Education, University of 
      Southampton Medical School, Southampton, UK.
FAU - Chahal, Harvinder
AU  - Chahal H
AD  - Department of Metabolism, Digestion and Reproduction, Imperial College, London, 
      UK.
FAU - Ahmed, Ahmed R
AU  - Ahmed AR
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
FAU - Cousins, Jonathan
AU  - Cousins J
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
FAU - Aldubaikhi, Ghadah
AU  - Aldubaikhi G
AD  - PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, 
      Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging 
      Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith 
      Hospital, London, UK.
FAU - Glover, Ben
AU  - Glover B
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
FAU - Falaschetti, Emanuela
AU  - Falaschetti E
AD  - Imperial College London, Department of Public Health, Imperial Clinical Trials 
      Unit, London, UK.
FAU - Ashrafian, Hutan
AU  - Ashrafian H
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
FAU - Roux, Carel W le
AU  - Roux CWL
AD  - Diabetes Complications Research Center, University College Dublin, Ireland.
FAU - Darzi, Ara
AU  - Darzi A
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
FAU - Byrne, James P
AU  - Byrne JP
AD  - Division of Surgery, University Hospital Southampton NHS Foundation Trust, 
      Southampton, UK.
FAU - Teare, Julian P
AU  - Teare JP
AD  - Department of Surgery and Cancer, Imperial College, London, UK.
LA  - eng
GR  - WT_/Wellcome Trust/United Kingdom
GR  - G0902002/MRC_/Medical Research Council/United Kingdom
GR  - 9MR/P002536/1/MRC_/Medical Research Council/United Kingdom
GR  - BB_/Biotechnology and Biological Sciences Research Council/United Kingdom
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ann Surg
JT  - Annals of surgery
JID - 0372354
SB  - IM
MH  - Adult
MH  - Diabetes Mellitus, Type 2/*surgery
MH  - Duodenum/*surgery
MH  - Female
MH  - Humans
MH  - *Jejunoileal Bypass/adverse effects
MH  - Jejunum/*surgery
MH  - Male
MH  - Middle Aged
MH  - Obesity/*surgery
MH  - Treatment Outcome
PMC - PMC8820769
COIS- Declaration of interests: A.R. received travel fees support from GI Dynamics. 
      A.D.M. has received honoraria for presentations and advisory board contribution 
      by Novo Nordisk, Boehringer Ingelheim, AstraZeneca, Johnson & Johnson and 
      research grant funding from Fractyl. A.P.G. reports funding supported by UK 
      Medical Research Council and Wellcome Trust, outside of the submitted work, is on 
      a Data Safety Monitoring Board for Novo Nordisk, and has received honoraria for 
      presentations and advisory board contribution by Janssen, Pfizer, Novo Nordisk, 
      Zafgen, Soleno Therapeutics Inc, and Millendo Theapeutics Inc, and Merck. A.R.A. 
      received educational grants from MSD and WL Gore. C.W.R. is a member of 
      scientific advisory board for Herbalife, GI Dynamics, NovoNordisk, Keyron, 
      Sanofi, has provided ad hoc consulting for Ethicon and Fractyl, occasional 
      speaking engagement for MSD, Boehringer Ingelheim and Lilly. J.P.T. received 
      travel fees support from GI Dynamics. The rest of the authors report no conflicts 
      of interest. The authors report no conflict of interests.
EDAT- 2021/10/15 06:00
MHDA- 2022/02/19 06:00
PMCR- 2022/02/07
CRDT- 2021/10/14 09:38
PHST- 2021/10/15 06:00 [pubmed]
PHST- 2022/02/19 06:00 [medline]
PHST- 2021/10/14 09:38 [entrez]
PHST- 2022/02/07 00:00 [pmc-release]
AID - 00000658-202203000-00007 [pii]
AID - ANNSURG-D-21-00442 [pii]
AID - 10.1097/SLA.0000000000004980 [doi]
PST - ppublish
SO  - Ann Surg. 2022 Mar 1;275(3):440-447. doi: 10.1097/SLA.0000000000004980.