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03-17-2016 | Metabolic surgery | Article

Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial

Journal: Diabetologia

Authors: David E. Cummings, David E. Arterburn, Emily O. Westbrook, Jessica N. Kuzma, Skye D. Stewart, Chun P. Chan, Steven N. Bock, Jeffrey T. Landers, Mario Kratz, Karen E. Foster-Schubert, David R. Flum

Publisher: Springer Berlin Heidelberg



Mounting evidence indicates that Roux-en-Y gastric bypass (RYGB) ameliorates type 2 diabetes, but randomised trials comparing surgical vs nonsurgical care are needed. With a parallel-group randomised controlled trial (RCT), we compared RYGB vs an intensive lifestyle and medical intervention (ILMI) for type 2 diabetes, including among patients with a BMI <35 kg/m2.


By use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, we screened 1,808 adults meeting inclusion criteria (age 25–64, with type 2 diabetes and a BMI 30–45 kg/m2). Of these, 43 were allocated via concealed, computer-generated random assignment in a 1:1 ratio to RYGB or ILMI. The latter involved ≥45 min of aerobic exercise 5 days per week, a dietitian-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for 1 year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at 1 year (HbA1c <6.0% [<42.1 mmol/mol], off all diabetes medicines).


Twenty-three volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention. Hence 15 in the RYGB group and 17 in the IMLI group were analysed throughout 1 year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had a longer diabetes duration (11.4 ± 4.8 vs 6.8 ± 5.2 years, p = 0.009). Weight loss at 1 year was 25.8 ± 14.5% vs 6.4 ± 5.8% after RYGB vs ILMI, respectively (p < 0.001). The ILMI exercise programme yielded a 22 ± 11% increase in \( \overset{\cdot }{V}{\mathrm{O}}_{2 \max } \) (p<0.0001), whereas \( \overset{\cdot }{V}{\mathrm{O}}_{2 \max } \) after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI (p = 0.002). The HbA1c decline over 1 year was only modestly more after RYGB than ILMI: from 7.7 ± 1.0% (60.7 mmol/mol) to 6.4 ± 1.6% (46.4 mmol/mol) vs 7.3 ± 0.9% (56.3 mmol/mol) to 6.9 ± 1.3% (51.9 mmol/mol), respectively (p = 0.04); however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred.


Compared with the most rigorous ILMI yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample.

Trial registration: NCT01295229
Murray CJ, Vos T, Lozano R et al (2012) Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 380:2197–2223CrossRefPubMed
Wong K, Glovaci D, Malik S et al (2012) Comparison of demographic factors and cardiovascular risk factor control among U.S. adults with type 2 diabetes by insulin treatment classification. J Diabetes Complications 26:169–174CrossRefPubMedPubMedCentral
Buchwald H, Estok R, Fahrbach K et al (2009) Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med 122:248–256 e5CrossRefPubMed
Thaler JP, Cummings DE (2009) Hormonal and metabolic mechanisms of diabetes remission after gastrointestinal surgery. Endocrinology 150:2518–2525CrossRefPubMed
Sjostrom L, Lindroos AK, Peltonen M et al (2004) Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 351:2683–2693CrossRefPubMed
Carlsson LM, Peltonen M, Ahlin S et al (2012) Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. N Engl J Med 367:695–704CrossRefPubMed
Sjostrom L, Peltonen M, Jacobson P et al (2012) Bariatric surgery and long-term cardiovascular events. JAMA 307:56–65CrossRefPubMed
Sjostrom L, Gummesson A, Sjostrom CD et al (2009) Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): a prospective, controlled intervention trial. Lancet Oncol 10:653–662CrossRefPubMed
Sjostrom L, Narbro K, Sjostrom CD et al (2007) Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 357:741–752CrossRefPubMed
Adams TD, Gress RE, Smith SC et al (2007) Long-term mortality after gastric bypass surgery. N Engl J Med 357:753–761CrossRefPubMed
Arterburn D, Flum DR, Westbrook EO et al (2013) A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes. Surg Obes Relat Dis 9:837–844CrossRefPubMed
Kolotkin RL, Crosby RD, Pendleton R, Strong M, Gress RE, Adams T (2003) Health-related quality of life in patients seeking gastric bypass surgery vs non-treatment-seeking controls. Obes Surg 13:371–377CrossRefPubMed
van Nunen AM, Wouters EJ, Vingerhoets AJ, Hox JJ, Geenen R (2007) The health-related quality of life of obese persons seeking or not seeking surgical or non-surgical treatment: a meta-analysis. Obes Surg 17:1357–1366CrossRefPubMedPubMedCentral
Encinosa WE, Bernard DM, Du D, Steiner CA (2009) Recent improvements in bariatric surgery outcomes. Med Care 47:531–535CrossRefPubMed
Courcoulas AP, Yanovski SZ, Bonds D et al (2014) Long-term outcomes of bariatric surgery: a National Institutes of Health symposium. JAMA Surg 149:1323–1329CrossRefPubMed
Schauer PR, Kashyap SR, Wolski K et al (2012) Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med 366:1567–1576CrossRefPubMedPubMedCentral
Mingrone G, Panunzi S, De Gaetano A et al (2012) Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med 366:1577–1585CrossRefPubMed
Ikramuddin S, Korner J, Lee WJ et al (2013) 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. JAMA 309:2240–2249CrossRefPubMedPubMedCentral
Dixon JB, O'Brien PE, Playfair J et al (2008) Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA 299:316–323PubMed
Halperin F, Ding SA, Simonson DC et al (2014) Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. JAMA Surg 149:716–726CrossRefPubMedPubMedCentral
Courcoulas AP, Goodpaster BH, Eagleton JK et al (2014) Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA Surg 149:707–715CrossRefPubMedPubMedCentral
Schauer PR, Bhatt DL, Kirwan JP et al (2014) Bariatric surgery versus intensive medical therapy for diabetes—3-year outcomes. N Engl J Med 370:2002–2013CrossRefPubMed
Ludwig DS, Ebbeling CB, Livingston EH (2012) Surgical vs lifestyle treatment for type 2 diabetes. JAMA 308:981–982CrossRefPubMed
Knowler WC, Barrett-Connor E, Fowler SE et al (2002) Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 346:393–403CrossRefPubMed
The Look AHEAD Research Group, Wing RR, Bolin P et al (2013) Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med 369:145–154CrossRefPubMedCentral
Inzucchi SE, Bergenstal RM, Buse JB et al (2012) Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 35:1364–1379CrossRefPubMedPubMedCentral
Buse JB, Caprio S, Cefalu WT et al (2009) How do we define cure of diabetes? Diabetes Care 32:2133–2135CrossRefPubMedPubMedCentral
Arterburn DE, Westbrook EO, Bogart TA, Sepucha KR, Bock SN, Weppner WG (2011) Randomized trial of a video-based patient decision aid for bariatric surgery. Obesity (Silver Spring) 19:1669–1675CrossRef
Gloy VL, Briel M, Bhatt DL et al (2013) Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ 347:f5934CrossRefPubMedPubMedCentral
Flum DR, Belle SH, King WC et al (2009) Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 361:445–454CrossRefPubMed
Buchwald H, Estok R, Fahrbach K, Banel D, Sledge I (2007) Trends in mortality in bariatric surgery: a systematic review and meta-analysis. Surgery 142:621–632, discussion 632–635CrossRefPubMed
Demaria EJ, Winegar DA, Pate VW, Hutcher NE, Ponce J, Pories WJ (2010) Early postoperative outcomes of metabolic surgery to treat diabetes from sites participating in the ASMBS bariatric surgery center of excellence program as reported in the Bariatric Outcomes Longitudinal Database. Ann Surg 252:559–566, discussion 566–567PubMed
Pournaras DJ, Aasheim ET, Sovik TT et al (2012) Effect of the definition of type II diabetes remission in the evaluation of bariatric surgery for metabolic disorders. Br J Surg 99:100–103CrossRefPubMed
CDCP NIH (1991) Gastrointestinal surgery for severe obesity. Ann Intern Med 115:956–961CrossRef

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