title: Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes.
abstract: BACKGROUND
  In short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus.
  
  
  METHODS
  We assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point was a glycated hemoglobin level of 6.0% or less.
  
  
  RESULTS
  The mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P=0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications.
  
  
  CONCLUSIONS
  Among obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.).
authors.affiliation: From the Bariatric and Metabolic Institute (P.R.S., S.A.B., A.A.), Lerner Research Institute (J.P.K.), Heart and Vascular Institute (K.W., C.E.P., E.S.H.K., S.E.N.), Urological and Kidney Institute (S.D.N.), and Endocrinology Institute (S.R.K.), Cleveland Clinic, Cleveland; and Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School - both in Boston (D.L.B.).
authors.forename: Philip R
authors.initials: PR
authors.lastname: Schauer
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: John P
authors.initials: JP
authors.lastname: Kirwan
authors.forename: Kathy
authors.initials: K
authors.lastname: Wolski
authors.forename: Stacy A
authors.initials: SA
authors.lastname: Brethauer
authors.forename: Sankar D
authors.initials: SD
authors.lastname: Navaneethan
authors.forename: Ali
authors.initials: A
authors.lastname: Aminian
authors.forename: Claire E
authors.initials: CE
authors.lastname: Pothier
authors.forename: Esther S H
authors.initials: ES
authors.lastname: Kim
authors.forename: Steven E
authors.initials: SE
authors.lastname: Nissen
authors.forename: Sangeeta R
authors.initials: SR
authors.lastname: Kashyap
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D008078:Cholesterol, LDL / Q000097:blood; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy; D015390:Gastric Bypass; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000601:surgery; D011183:Postoperative Complications; D011788:Quality of Life; D014280:Triglycerides / Q000097:blood; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D014280:Triglycerides