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

Rinki Murphy, Nicholas J Evennett, Michael G Clarke, Steven J Robinson, Lee Humphreys, Bronwen Jones, David D Kim, Richard Cutfield, Lindsay D Plank, Hisham Hammodat, Michael W C Booth, Rinki Murphy, Nicholas J Evennett, Michael G Clarke, Steven J Robinson, Lee Humphreys, Bronwen Jones, David D Kim, Richard Cutfield, Lindsay D Plank, Hisham Hammodat, Michael W C Booth

Abstract

Introduction: Type 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<6% (<42 mmol/mol) without the use of diabetes medication at 5 years.

Methods and analysis: Single-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/m(2) 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<5.7% (39 mmol/mol) or HbA1c<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 dissemination: Ethics 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 numbers: ACTRN12611000751976, NCT01486680; Pre-results.

Keywords: Roux-en-Y gastric bypass; Sleeve gastrectomy; bariatric surgery; morbid obesity; type 2 diabetes.

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/

Figures

Figure 1
Figure 1
CONSORT diagram showing the proposed flow of participants through the sleeve gastrectomy versus gastric bypass trial for type 2 diabetes.
Figure 2
Figure 2
Endocrinology evaluation and treatment protocol for trial patients.

References

    1. Yip S, Plank LD, Murphy R. Gastric bypass and sleeve gastrectomy for type 2 diabetes: a systematic review and meta-analysis of outcomes. Obes Surg 2013;23:1994–2003. 10.1007/s11695-013-1030-z
    1. Li J, Lai D, Wu D. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy to treat morbid obesity-related comorbidities: a systematic review and meta-analysis. Obes Surg 2016;26:429–42. 10.1007/s11695-015-1996-9
    1. Schauer PR, Kashyap SR, Wolski K et al. . Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med 2012;366:1567–76. 10.1056/NEJMoa1200225
    1. Keidar A, Hershkop KJ, Marko L et al. . Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial. Diabetologia 2013;56:1914–18. 10.1007/s00125-013-2965-2
    1. Lee WJ, Chong K, Ser KH et al. . Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg 2011;146:143–8. 10.1001/archsurg.2010.326
    1. Mahawar KK, Parikh C, Carr WR et al. . Primary banded Roux-en-Y gastric bypass: a systematic review. Obes Surg 2014;24:1771–92. 10.1007/s11695-014-1346-3
    1. Vetter ML, Cardillo S, Rickels MR et al. . Narrative review: effect of bariatric surgery on type 2 diabetes mellitus. Ann Intern Med 2009;150:94–103. 10.7326/0003-4819-150-2-200901200-00007
    1. Iannelli A, Anty R, Piche T et al. . Impact of laparoscopic Roux-en-Y gastric bypass on metabolic syndrome, inflammation, and insulin resistance in super versus morbidly obese women. Obes Surg 2009;19:577–82. 10.1007/s11695-008-9764-8
    1. Aron-Wisnewsky J, Dore J, Clement K. The importance of the gut microbiota after bariatric surgery. Nat Rev Gastroenterol Hepatol 2012;9:590–8. 10.1038/nrgastro.2012.161
    1. Buse JB, Caprio S, Cefalu WT et al. . How do we define cure of diabetes? Diabetes Care 2009;32:2133–5. 10.2337/dc09-9036
    1. Elley CR, Robinson E, Kenealy T et al. . Derivation and validation of a new cardiovascular risk score for people with type 2 diabetes: the New Zealand diabetes cohort study. Diabetes Care 2010;33:1347–52. 10.2337/dc09-1444
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13. 10.1097/
    1. Bjelland I, Dahl AA, Haug TT et al. . The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002;52:69–77. 10.1016/S0022-3999(01)00296-3
    1. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.
    1. Yi J, Warunek D, Craft D. Degradation and stabilization of peptide hormones in human blood specimens. PLoS One 2015;10:e0134427 10.1371/journal.pone.0134427
    1. Miras AD, Risstad H, Baqai N et al. . Application of the international diabetes federation and American diabetes association criteria in the assessment of metabolic control after bariatric surgery. Diabetes Obes Metab 2014;16:86–9. 10.1111/dom.12177
    1. Bessler M, Daud A, Kim T et al. . Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results. Surg Obes Relat Dis 2007;3:480–4. 10.1111/dom.12177
    1. Awad W, Garay A, Martinez C. Ten years experience of banded gastric bypass: does it make a difference? Obes Surg 2012;22:271–8. 10.1007/s11695-011-0555-2
    1. Heneghan HM, Annaberdyev S, Eldar S et al. . Banded Roux-en-Y gastric bypass for the treatment of morbid obesity. Surg Obes Relat Dis 2014;10:210–16. 10.1016/j.soard.2013.10.016

Source: PubMed

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