Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial | Bariatric Surgery | JAMA Surgery | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 18.204.227.34. Please contact the publisher to request reinstatement.
1.
Wing  RR, Bolin  P, Brancati  FL,  et al; Look AHEAD Research Group.  Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.  N Engl J Med. 2013;369(2):145-154.PubMedGoogle ScholarCrossref
2.
Buchwald  H, Estok  R, Fahrbach  K,  et al.  Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis.  Am J Med. 2009;122(3):248-256.e5. PubMedGoogle ScholarCrossref
3.
Pories  WJ, Swanson  MS, MacDonald  KG,  et al.  Who would have thought it? an operation proves to be the most effective therapy for adult-onset diabetes mellitus.  Ann Surg. 1995;222(3):339-350; discussion 350-352. PubMedGoogle ScholarCrossref
4.
Rubino  F, Schauer  PR, Kaplan  LM, Cummings  DE.  Metabolic surgery to treat type 2 diabetes: clinical outcomes and mechanisms of action.  Annu Rev Med. 2010;61:393-411.PubMedGoogle ScholarCrossref
5.
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(4):467-484; discussion 484-485. PubMedGoogle Scholar
6.
Dixon  JB, O’Brien  PE, Playfair  J,  et al.  Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial.  JAMA. 2008;299(3):316-323.PubMedGoogle ScholarCrossref
7.
Ikramuddin  S, Korner  J, Lee  WJ,  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.  JAMA. 2013;309(21):2240-2249.PubMedGoogle ScholarCrossref
8.
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(17):1577-1585.PubMedGoogle ScholarCrossref
9.
Schauer  PR, Bhatt  DL, Kirwan  JP,  et al; STAMPEDE Investigators.  Bariatric surgery versus intensive medical therapy for diabetes: 3-year outcomes.  N Engl J Med. 2014;370(21):2002-2013.PubMedGoogle ScholarCrossref
10.
Maggard-Gibbons  M, Maglione  M, Livhits  M,  et al.  Bariatric surgery for weight loss and glycemic control in nonmorbidly obese adults with diabetes: a systematic review.  JAMA. 2013;309(21):2250-2261.PubMedGoogle ScholarCrossref
11.
Courcoulas  AP, Goodpaster  BH, Eagleton  JK,  et al.  Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.  JAMA Surg. 2014;149(7):707-715.PubMedGoogle ScholarCrossref
12.
Ryan  DH, Espeland  MA, Foster  GD,  et al; Look AHEAD Research Group.  Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes.  Control Clin Trials. 2003;24(5):610-628.PubMedGoogle ScholarCrossref
13.
Diabetes Prevention Program (DPP) Research Group.  The Diabetes Prevention Program (DPP): description of lifestyle intervention.  Diabetes Care. 2002;25(12):2165-2171.PubMedGoogle ScholarCrossref
14.
Wadden  TA, Neiberg  RH, Wing  RR,  et al; Look AHEAD Research Group.  Four-year weight losses in the Look AHEAD study: factors associated with long-term success.  Obesity (Silver Spring). 2011;19(10):1987-1998.PubMedGoogle ScholarCrossref
15.
Buse  JB, Caprio  S, Cefalu  WT,  et al.  How do we define cure of diabetes?  Diabetes Care. 2009;32(11):2133-2135.PubMedGoogle ScholarCrossref
16.
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.PubMedGoogle ScholarCrossref
17.
O’Brien  PE, Dixon  JB, Laurie  C,  et al.  Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial.  Ann Intern Med. 2006;144(9):625-633.PubMedGoogle ScholarCrossref
18.
Courcoulas  AP, Christian  NJ, Belle  SH,  et al; Longitudinal Assessment of Bariatric Surgery (LABS) Consortium.  Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity.  JAMA. 2013;310(22):2416-2425.PubMedGoogle Scholar
19.
Pi-Sunyer  X, Blackburn  G, Brancati  FL,  et al; Look AHEAD Research Group.  Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the Look AHEAD trial.  Diabetes Care. 2007;30(6):1374-1383.PubMedGoogle ScholarCrossref
20.
Wing  RR; Look AHEAD Research Group.  Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial.  Arch Intern Med. 2010;170(17):1566-1575.PubMedGoogle Scholar
21.
Halperin  F, Ding  SA, Simonson  DC,  et al.  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. 2014;149(7):716-726.PubMedGoogle ScholarCrossref
22.
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(17):1567-1576.PubMedGoogle ScholarCrossref
23.
Courcoulas  AP, Yanovski  SZ, Bonds  D,  et al.  Long-term outcomes of bariatric surgery: a National Institutes of Health symposium.  JAMA Surg. 2014;149(12):1323-1329. PubMedGoogle ScholarCrossref
24.
Wolfe  BM, Belle  SH.  Long-term risks and benefits of bariatric surgery: a research challenge.  JAMA. 2014;312(17):1792-1793.PubMedGoogle ScholarCrossref
Original Investigation
October 2015

Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  • 2Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
  • 3Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
  • 4Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, South Carolina
  • 5School of Nursing, Duquesne University, Pittsburgh, Pennsylvania
  • 6Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 7Physical Activity and Weight Management Research Center, Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA Surg. 2015;150(10):931-940. doi:10.1001/jamasurg.2015.1534
Abstract

Importance  Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).

Objective  To compare the remission of T2DM following surgical and nonsurgical treatments.

Design, Setting, and Participants  In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.

Interventions  Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.

Main Outcomes and Measures  Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.

Results  Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention–alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01).

Conclusions and Relevance  Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.

Trial Registration  clinicaltrials.gov Identifier: NCT01047735

×