Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial

Aruchuna Ruban; Alexander D. Miras; Michael A. Glaysher; Anthony P. Goldstone; Christina G. Prechtl; Nicholas Johnson; Navpreet Chhina; Werd Al-Najim; Madhawi Aldhwayan; Natalia Klimowska-Nassar; Claire Smith; Joanne Lord; Jia V. Li; Lilliam Flores; Moaz Al-Lababidi; Georgios K. Dimitriadis; Mayank Patel; Michael Moore; Harvinder Chahal; Ahmed R. Ahmed; Jonathan Cousins; Ghadah Aldubaikhi; Ben Glover; Emanuela Falaschetti; Hutan Ashrafian; Carel W.Le Roux; Ara Darzi; James P. Byrne; Julian P. Teare

doi:10.1097/SLA.0000000000004980

Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial

Aruchuna Ruban, Alexander D. Miras, Michael A. Glaysher, Anthony P. Goldstone, Christina G. Prechtl, Nicholas Johnson, Navpreet Chhina, Werd Al-Najim, Madhawi Aldhwayan, Natalia Klimowska-Nassar, Claire Smith, Joanne Lord, Jia V. Li, Lilliam Flores, Moaz Al-Lababidi, Georgios K. Dimitriadis, Mayank Patel, Michael Moore, Harvinder Chahal, Ahmed R. AhmedJonathan Cousins, Ghadah Aldubaikhi, Ben Glover, Emanuela Falaschetti, Hutan Ashrafian, Carel W.Le Roux, Ara Darzi, James P. Byrne, Julian P. Teare

Research output: Contribution to journal › Article › peer-review

28 Citations (Scopus)

63 Downloads (Pure)

Abstract

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 12months and for 12months 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 12months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24months.
Results: There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12months [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 12months (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.

Original language	English
Pages (from-to)	440-447
Number of pages	8
Journal	Annals of Surgery
Volume	275
Issue number	3
Early online date	14 Jun 2021
DOIs	https://doi.org/10.1097/SLA.0000000000004980
Publication status	Published (in print/issue) - 1 Mar 2022

Bibliographical note

Funding Information:
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.

Funding Information:
This study was funded by the Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04. The devices and nutritional supplements were kindly provided free of charge by GI Dynamics and Nutricia Advanced Medical Nutrition respectively. Infrastructure support was provided by the NIHR Imperial Biomedical Research Center, NIHR Imperial and Clinical Research Facility, London, NIHR Southampton Biomedical Research Center UK and NIHR Southampton clinical research facility, Southampton, UK. The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the UK Department of Health and Social Care. The Division of Diabetes, Endocrinology and Metabolism is funded by grants from the UK Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council, and the NIHR; an Integrative Mammalian Biology Capacity Building Award; and an FP7- HEALTH-2009–241592 EuroCHIP grant. It is also supported by the NIHR Biomedical Research Center Funding Scheme. JVL is funded by a MRC New Investigator Grant 9MR/P002536/1) and ERC Starting Grant (715662) as well as supported by the NIHR Imperial Biomedical Research Center (BRC).

Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.

Keywords

duodenal-jejunal bypass liner
endobarrier
endoscopic bariatric therapies
obesity
type 2 diabetes mellitus

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1097/SLA.0000000000004980Licence: CC BY

Duodenal_Jejunal_Bypass_Liner_for_the_management...Final published version, 581 KBLicence: CC BY

Cite this

Ruban, A., Miras, A. D., Glaysher, M. A., Goldstone, A. P., Prechtl, C. G., Johnson, N., Chhina, N., Al-Najim, W., Aldhwayan, M., Klimowska-Nassar, N., Smith, C., Lord, J., Li, J. V., Flores, L., Al-Lababidi, M., Dimitriadis, G. K., Patel, M., Moore, M., Chahal, H., ... Teare, J. P. (2022). Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial. Annals of Surgery, 275(3), 440-447. https://doi.org/10.1097/SLA.0000000000004980

@article{4e517c64bdf145498c9ffa7bebb8e351,

title = "Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial",

abstract = "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 12months and for 12months 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 12months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24months.Results: There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12months [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 12months (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.",

keywords = "duodenal-jejunal bypass liner, endobarrier, endoscopic bariatric therapies, obesity, type 2 diabetes mellitus",

author = "Aruchuna Ruban and Miras, {Alexander D.} and Glaysher, {Michael A.} and Goldstone, {Anthony P.} and Prechtl, {Christina G.} and Nicholas Johnson and Navpreet Chhina and Werd Al-Najim and Madhawi Aldhwayan and Natalia Klimowska-Nassar and Claire Smith and Joanne Lord and Li, {Jia V.} and Lilliam Flores and Moaz Al-Lababidi and Dimitriadis, {Georgios K.} and Mayank Patel and Michael Moore and Harvinder Chahal and Ahmed, {Ahmed R.} and Jonathan Cousins and Ghadah Aldubaikhi and Ben Glover and Emanuela Falaschetti and Hutan Ashrafian and Roux, {Carel W.Le} and Ara Darzi and Byrne, {James P.} and Teare, {Julian P.}",

note = "Funding Information: 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. Funding Information: This study was funded by the Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04. The devices and nutritional supplements were kindly provided free of charge by GI Dynamics and Nutricia Advanced Medical Nutrition respectively. Infrastructure support was provided by the NIHR Imperial Biomedical Research Center, NIHR Imperial and Clinical Research Facility, London, NIHR Southampton Biomedical Research Center UK and NIHR Southampton clinical research facility, Southampton, UK. The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the UK Department of Health and Social Care. The Division of Diabetes, Endocrinology and Metabolism is funded by grants from the UK Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council, and the NIHR; an Integrative Mammalian Biology Capacity Building Award; and an FP7- HEALTH-2009–241592 EuroCHIP grant. It is also supported by the NIHR Biomedical Research Center Funding Scheme. JVL is funded by a MRC New Investigator Grant 9MR/P002536/1) and ERC Starting Grant (715662) as well as supported by the NIHR Imperial Biomedical Research Center (BRC). Publisher Copyright: {\textcopyright} 2022 Lippincott Williams and Wilkins. All rights reserved.",

year = "2022",

month = mar,

day = "1",

doi = "10.1097/SLA.0000000000004980",

language = "English",

volume = "275",

pages = "440--447",

journal = "Annals of Surgery",

issn = "0003-4932",

publisher = "Lippincott Williams and Wilkins",

number = "3",

}

Ruban, A, Miras, AD, Glaysher, MA, Goldstone, AP, Prechtl, CG, Johnson, N, Chhina, N, Al-Najim, W, Aldhwayan, M, Klimowska-Nassar, N, Smith, C, Lord, J, Li, JV, Flores, L, Al-Lababidi, M, Dimitriadis, GK, Patel, M, Moore, M, Chahal, H, Ahmed, AR, Cousins, J, Aldubaikhi, G, Glover, B, Falaschetti, E, Ashrafian, H, Roux, CWL, Darzi, A, Byrne, JP & Teare, JP 2022, 'Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial', Annals of Surgery, vol. 275, no. 3, pp. 440-447. https://doi.org/10.1097/SLA.0000000000004980

TY - JOUR

T1 - Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity

T2 - A Multicenter Randomized Controlled Trial

AU - Ruban, Aruchuna

AU - Miras, Alexander D.

AU - Glaysher, Michael A.

AU - Goldstone, Anthony P.

AU - Prechtl, Christina G.

AU - Johnson, Nicholas

AU - Chhina, Navpreet

AU - Al-Najim, Werd

AU - Aldhwayan, Madhawi

AU - Klimowska-Nassar, Natalia

AU - Smith, Claire

AU - Lord, Joanne

AU - Li, Jia V.

AU - Flores, Lilliam

AU - Al-Lababidi, Moaz

AU - Dimitriadis, Georgios K.

AU - Patel, Mayank

AU - Moore, Michael

AU - Chahal, Harvinder

AU - Ahmed, Ahmed R.

AU - Cousins, Jonathan

AU - Aldubaikhi, Ghadah

AU - Glover, Ben

AU - Falaschetti, Emanuela

AU - Ashrafian, Hutan

AU - Roux, Carel W.Le

AU - Darzi, Ara

AU - Byrne, James P.

AU - Teare, Julian P.

N1 - Funding Information: 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. Funding Information: This study was funded by the Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04. The devices and nutritional supplements were kindly provided free of charge by GI Dynamics and Nutricia Advanced Medical Nutrition respectively. Infrastructure support was provided by the NIHR Imperial Biomedical Research Center, NIHR Imperial and Clinical Research Facility, London, NIHR Southampton Biomedical Research Center UK and NIHR Southampton clinical research facility, Southampton, UK. The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the UK Department of Health and Social Care. The Division of Diabetes, Endocrinology and Metabolism is funded by grants from the UK Medical Research Council (MRC), Biotechnology and Biological Sciences Research Council, and the NIHR; an Integrative Mammalian Biology Capacity Building Award; and an FP7- HEALTH-2009–241592 EuroCHIP grant. It is also supported by the NIHR Biomedical Research Center Funding Scheme. JVL is funded by a MRC New Investigator Grant 9MR/P002536/1) and ERC Starting Grant (715662) as well as supported by the NIHR Imperial Biomedical Research Center (BRC). Publisher Copyright: © 2022 Lippincott Williams and Wilkins. All rights reserved.

PY - 2022/3/1

Y1 - 2022/3/1

N2 - 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 12months and for 12months 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 12months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24months.Results: There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12months [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 12months (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.

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 12months and for 12months 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 12months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24months.Results: There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12months [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 12months (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.

KW - duodenal-jejunal bypass liner

KW - endobarrier

KW - endoscopic bariatric therapies

KW - obesity

KW - type 2 diabetes mellitus

UR - http://www.scopus.com/inward/record.url?scp=85124173297&partnerID=8YFLogxK

UR - https://spiral.imperial.ac.uk/handle/10044/1/95008

U2 - 10.1097/SLA.0000000000004980

DO - 10.1097/SLA.0000000000004980

M3 - Article

C2 - 34647708

AN - SCOPUS:85124173297

SN - 0003-4932

VL - 275

SP - 440

EP - 447

JO - Annals of Surgery

JF - Annals of Surgery

IS - 3

ER -

Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this