title: Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01047735.
authors.affiliation: Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Anita P
authors.initials: AP
authors.lastname: Courcoulas
authors.affiliation: Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania3Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania.
authors.forename: Steven H
authors.initials: SH
authors.lastname: Belle
authors.affiliation: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, South Carolina.
authors.forename: Rebecca H
authors.initials: RH
authors.lastname: Neiberg
authors.affiliation: Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Sheila K
authors.initials: SK
authors.lastname: Pierson
authors.affiliation: Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Jessie K
authors.initials: JK
authors.lastname: Eagleton
authors.affiliation: School of Nursing, Duquesne University, Pittsburgh, Pennsylvania.
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Kalarchian
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: James P
authors.initials: JP
authors.lastname: DeLany
authors.affiliation: Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, South Carolina.
authors.forename: Wei
authors.initials: W
authors.lastname: Lang
authors.affiliation: Physical Activity and Weight Management Research Center, Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: John M
authors.initials: JM
authors.lastname: Jakicic
mesh_terms: D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000628:therapy*; D005260:Female; D015390:Gastric Bypass; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome