Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial

Ricardo Vitor Cohen, Tiago Veiga Pereira, Cristina Mamédio Aboud, Pedro Paulo de Paris Caravatto, Tarissa Beatrice Zanata Petry, José Luis Lopes Correa, Carlos Aurélio Schiavon, Mariangela Correa, Carlos Eduardo Pompílio, Fernando Nogueira Quirino Pechy, Carel W le Roux, MOMS Study Investigators, Ricardo Vitor Cohen, Tiago Veiga Pereira, Cristina Mamédio Aboud, Pedro Paulo de Paris Caravatto, Tarissa Beatrice Zanata Petry, José Luis Lopes Correa, Carlos Aurélio Schiavon, Mariangela Correa, Carlos Eduardo Pompílio, Fernando Nogueira Quirino Pechy, Carel W le Roux, MOMS Study Investigators

Abstract

Introduction: There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM).

Purpose: The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30-34.9 kg/m2.

Methods and analysis: This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m2) will be randomly allocated to receive either RYGB plus BMT or BMT alone. The primary outcome is the change in the urine albumin-to-creatinine ratio (uACR) captured as the proportion of patients who achieved nephropathy remission (uACR<30 mg/g of albumin/mg of creatinine) in an isolated urine sample over 12, 24 and 60 months.

Ethics and dissemination: The study was approved by the local Institutional Review Board. This study represents the first RCT comparing RYGB plus BMT versus BMT alone for patients with T2DM with a BMI below 35 kg/m2.

Trial registration number: NCT01821508; Pre-results.

Keywords: diabetes mellitus type 2; gastric bypass; metabolic surgery.

Conflict of interest statement

Conflicts of Interest: None declared.

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
Simplified MOMS algorithm. BMT, best medical treatment; HbA1c, glycated haemoglobin; MOMS, Microvascular Outcomes after Metabolic Surgery; RYGB, Roux-en-Y gastric bypass.
Figure 2
Figure 2
CONSORT 2010 standard RCT flow diagram for MOMS trial. BMT, best medical treatment; CONSORT, Consolidated Standards of Reporting Trials; GAD, glutamic acid decarboxylase; RYGB, Roux-en-Y gastric bypass.
Figure 3
Figure 3
Laparoscopic RYGB. RYGB, Roux-en-Y gastric bypass.

References

    1. Schauer PR, Bhatt DL, Kirwan JP et al. . Bariatric surgery versus intensive medical therapy for diabetes—3-year outcomes. N Engl J Med 2014;370:2002–13. 10.1056/NEJMoa1401329
    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. Ikramuddin S, Korner J, Lee W-J et al. . Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the diabetes surgery study randomized clinical trial Roux-en-Y gastric bypass and diabetes. JAMA 2013;309:2240–9. 10.1001/jama.2013.5835
    1. Ikramuddin S, Billington CJ, Lee WJ et al. . Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial. Lancet Diabetes Endocrinol 2015;3:413–22. 10.1016/S2213-8587(15)00089-3
    1. Mingrone G, Panunzi S, De Gaetano A et al. . Bariatric–metabolic surgery versus conventional medical treatment in obese patients with type 2 diabetes: 5 year follow-up of an open-label, single-centre randomised controlled trial. Lancet 2015;386:964–73. 10.1016/S0140-6736(15)00075-6
    1. Mingrone G, Panunzi S, De Gaetano A et al. . Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med 2012;366:1577–85. 10.1056/NEJMoa1200111
    1. Gloy VL, Briel M, Bhatt DL et al. . Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ 2013;347:f5934 10.1136/bmj.f5934
    1. Sjöholm K, Anveden Å, Peltonen M et al. . Evaluation of current eligibility criteria for bariatric surgery: diabetes prevention and risk factor changes in the Swedish Obese Subjects (SOS) study. Diabetes Care 2013;36:1335–40. 10.2337/dc12-1395
    1. Sjöström L, Peltonen M, Jacobson P et al. . Association of bariatric surgery with long-term remission of type 2 diabetes and with microvascular and macrovascular complications. JAMA 2014;311:2297 10.1001/jama.2014.5988
    1. Ferrannini E, Mingrone G. Impact of different bariatric surgical procedures on insulin action and cell beta-cell function in type 2 diabetes. Diabetes Care 2009;32:514–20. 10.2337/dc08-1762
    1. Sjöström L, Peltonen M, Jacobson P et al. . Bariatric surgery and long-term cardiovascular events. JAMA 2012;307:56–65. 10.1001/jama.2011.1914
    1. Romeo S, Maglio C, Burza MA et al. . Cardiovascular events after bariatric surgery in obese subjects with type 2 diabetes. Diabetes Care 2012;35:2613–17. 10.2337/dc12-0193
    1. Adams TD, Gress RE, Smith SC et al. . Long-term mortality after gastric bypass surgery. N Engl J Med 2007;357:753–61. 10.1056/NEJMoa066603
    1. Adams TD, Davidson LE, Litwin SE et al. . Health benefits of gastric bypass surgery after 6 years. JAMA 2012;308:1122–31. 10.1001/2012.jama.11164
    1. Adams TD, Pendleton RC, Strong MB et al. . Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese. Obesity (Silver Spring) 2010;18:121–30. 10.1038/oby.2009.178
    1. Rubino F, Amiel SA. Is the gut the “Sweet Spot” for the treatment of diabetes? Diabetes 2014;63:2225–8. 10.2337/db14-0402
    1. Pories WJ, Dohm LG, Mansfield CJ. Beyond the BMI: the search for better guidelines for bariatric surgery. Obesity (Silver Spring) 2010;18:865–71. 10.1038/oby.2010.8
    1. le Roux CW, Aylwin SJB, Batterham RL et al. . Gut hormone profiles following bariatric surgery favor an anorectic state, facilitate weight loss, and improve metabolic parameters. Ann Surg 2006;243:108 10.1097/01.sla.0000183349.16877.84
    1. Cummings DE, Cohen RV. Beyond BMI: the need for new guidelines governing the use of bariatric and metabolic surgery. Lancet Diabetes Endocrinol 2014;2:175–81. 10.1016/S2213-8587(13)70198-0
    1. Cohen R. Bariatric surgery: time to move beyond clinical outcomes. Lancet Diabetes Endocrinol 2015;3:829–31. 10.1016/S2213-8587(15)00320-4
    1. Sharma AM, Kushner RF. A proposed clinical staging system for obesity. Int J Obes 2009;33:289–95. 10.1038/ijo.2009.2
    1. DeFronzo RA, Ferrannini E. Insulin resistance: a multifaceted syndrome responsible for NIDDM, obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Diabetes Care 1991;14:173–94. 10.2337/diacare.14.3.173
    1. Knowler WC, Fowler SE, Hamman RF, Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet 2009;374:1677–86. 10.1016/S0140-6736(09)61457-4
    1. American Diabetes Association. Standards of medical care in diabetes--2013. Diabetes Care 2013;36(Suppl 1):S11–66. 10.2337/dc13-S011
    1. Afkarian M, Sachs MC, Kestenbaum B et al. . Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol 2013;24:302–8. 10.1681/ASN.2012070718
    1. Gallagher H, Suckling RJ. Diabetic nephropathy—where are we on the journey from pathophysiology to treatment? Diabetes Obes Metab 2016;18:641–7. 10.1111/dom.12630
    1. Chen Y, Corsino L, Shantavasinkul PC et al. . Gastric bypass surgery leads to long-term remission or improvement of type 2 diabetes and significant decrease of microvascular and macrovascular complications. Ann Surg 2016;263:1138–42. 10.1097/SLA.0000000000001509
    1. Upala S, Wijarnpreecha K, Congrete S et al. . Bariatric surgery reduces urinary albumin excretion in diabetic nephropathy—a systematic review and meta-analysis. Surg Obes Relat Dis 2016;12:1037–44. 10.1016/j.soard.2015.11.019
    1. Schauer PR, Burguera B, Ikramuddin S et al. . Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg 2003;238:467–84. 10.1097/01.sla.0000089851.41115.1b
    1. Cohen RV, Pinheiro JC, Schiavon CA et al. . Effects of gastric bypass surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care 2012;35:1420–8. 10.2337/dc11-2289
    1. Cummings DE, Cohen RV. Bariatric/metabolic surgery to treat type 2 diabetes in patients with a BMI<35 kg/m 2. Diabetes Care 2016;39:924–33. 10.2337/dc16-0350
    1. White IR, Horton NJ, Carpenter J et al. . Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ 2011;342:d40 10.1136/bmj.d40

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren