Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol

IntroductionType 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscop...

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Veröffentlicht in:BMJ open 2016-07, Vol.6 (7), p.e011416-e011416
Hauptverfasser: Murphy, Rinki, Evennett, Nicholas J, Clarke, Michael G, Robinson, Steven J, Humphreys, Lee, Jones, Bronwen, Kim, David D, Cutfield, Richard, Plank, Lindsay D, Hammodat, Hisham, Booth, Michael W C
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container_issue 7
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container_title BMJ open
container_volume 6
creator Murphy, Rinki
Evennett, Nicholas J
Clarke, Michael G
Robinson, Steven J
Humphreys, Lee
Jones, Bronwen
Kim, David D
Cutfield, Richard
Plank, Lindsay D
Hammodat, Hisham
Booth, Michael W C
description IntroductionType 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c
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Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c&lt;6% (&lt;42 mmol/mol) without the use of diabetes medication at 5 years.Methods and analysisSingle-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20–55 years, T2D of at least 6 months duration and body mass index 35–65 kg/m2 for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c&lt;5.7% (39 mmol/mol) or HbA1c&lt;6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission.Ethics and disseminationEthics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings.Trial registration numbersACTRN12611000751976, NCT01486680; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-011416</identifier><identifier>PMID: 27377635</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adult ; Blood pressure ; Body composition ; Body Mass Index ; Clinical Protocols ; Clinical trials ; Diabetes ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - surgery ; Double-Blind Method ; Female ; Gastrectomy - methods ; Gastric Bypass - methods ; Gastrointestinal surgery ; Glucose ; Glycated Hemoglobin A - metabolism ; Hormones ; Humans ; Laparoscopy ; Laparoscopy - methods ; Male ; Microbiota ; Middle Aged ; Normal distribution ; Obesity, Morbid - surgery ; Quality of Life ; Remission (Medicine) ; Research Design ; Surgery ; Treatment Outcome ; Weight Loss ; Young Adult</subject><ispartof>BMJ open, 2016-07, Vol.6 (7), p.e011416-e011416</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Published by the BMJ Publishing Group Limited. 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Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c&lt;6% (&lt;42 mmol/mol) without the use of diabetes medication at 5 years.Methods and analysisSingle-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20–55 years, T2D of at least 6 months duration and body mass index 35–65 kg/m2 for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c&lt;5.7% (39 mmol/mol) or HbA1c&lt;6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission.Ethics and disseminationEthics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. 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Evennett, Nicholas J ; Clarke, Michael G ; Robinson, Steven J ; Humphreys, Lee ; Jones, Bronwen ; Kim, David D ; Cutfield, Richard ; Plank, Lindsay D ; Hammodat, Hisham ; Booth, Michael W C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-e20ae780b0a461f3cac0dc9fa000e8303a8077103c6448b867af8abc10be1aab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Blood pressure</topic><topic>Body composition</topic><topic>Body Mass Index</topic><topic>Clinical Protocols</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - surgery</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Gastrectomy - methods</topic><topic>Gastric Bypass - methods</topic><topic>Gastrointestinal surgery</topic><topic>Glucose</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Hormones</topic><topic>Humans</topic><topic>Laparoscopy</topic><topic>Laparoscopy - methods</topic><topic>Male</topic><topic>Microbiota</topic><topic>Middle Aged</topic><topic>Normal distribution</topic><topic>Obesity, Morbid - surgery</topic><topic>Quality of Life</topic><topic>Remission (Medicine)</topic><topic>Research Design</topic><topic>Surgery</topic><topic>Treatment Outcome</topic><topic>Weight Loss</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Murphy, Rinki</creatorcontrib><creatorcontrib>Evennett, Nicholas J</creatorcontrib><creatorcontrib>Clarke, Michael G</creatorcontrib><creatorcontrib>Robinson, Steven J</creatorcontrib><creatorcontrib>Humphreys, Lee</creatorcontrib><creatorcontrib>Jones, Bronwen</creatorcontrib><creatorcontrib>Kim, David D</creatorcontrib><creatorcontrib>Cutfield, Richard</creatorcontrib><creatorcontrib>Plank, Lindsay D</creatorcontrib><creatorcontrib>Hammodat, Hisham</creatorcontrib><creatorcontrib>Booth, Michael W C</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c&lt;6% (&lt;42 mmol/mol) without the use of diabetes medication at 5 years.Methods and analysisSingle-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20–55 years, T2D of at least 6 months duration and body mass index 35–65 kg/m2 for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c&lt;5.7% (39 mmol/mol) or HbA1c&lt;6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission.Ethics and disseminationEthics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings.Trial registration numbersACTRN12611000751976, NCT01486680; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>27377635</pmid><doi>10.1136/bmjopen-2016-011416</doi><oa>free_for_read</oa></addata></record>
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subjects Adult
Blood pressure
Body composition
Body Mass Index
Clinical Protocols
Clinical trials
Diabetes
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - surgery
Double-Blind Method
Female
Gastrectomy - methods
Gastric Bypass - methods
Gastrointestinal surgery
Glucose
Glycated Hemoglobin A - metabolism
Hormones
Humans
Laparoscopy
Laparoscopy - methods
Male
Microbiota
Middle Aged
Normal distribution
Obesity, Morbid - surgery
Quality of Life
Remission (Medicine)
Research Design
Surgery
Treatment Outcome
Weight Loss
Young Adult
title Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol
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