title: 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.
abstract: OBJECTIVE
  Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown.
  
  
  OBJECTIVE
  To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors.
  
  
  METHODS
  A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008.
  
  
  METHODS
  Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized.
  
  
  METHODS
  Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg.
  
  
  RESULTS
  All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group.
  
  
  CONCLUSIONS
  In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00641251.
authors.affiliation: Department of Surgery, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA. ikram001@umn.edu
authors.forename: Sayeed
authors.initials: S
authors.lastname: Ikramuddin
authors.forename: Judith
authors.initials: J
authors.lastname: Korner
authors.forename: Wei-Jei
authors.initials: WJ
authors.lastname: Lee
authors.forename: John E
authors.initials: JE
authors.lastname: Connett
authors.forename: William B
authors.initials: WB
authors.lastname: Inabnet
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billington
authors.forename: Avis J
authors.initials: AJ
authors.lastname: Thomas
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Leslie
authors.forename: Keong
authors.initials: K
authors.lastname: Chong
authors.forename: Robert W
authors.initials: RW
authors.lastname: Jeffery
authors.forename: Leaque
authors.initials: L
authors.lastname: Ahmed
authors.forename: Adrian
authors.initials: A
authors.lastname: Vella
authors.forename: Lee-Ming
authors.initials: LM
authors.lastname: Chuang
authors.forename: Marc
authors.initials: M
authors.lastname: Bessler
authors.forename: Michael G
authors.initials: MG
authors.lastname: Sarr
authors.forename: James M
authors.initials: JM
authors.lastname: Swain
authors.forename: Patricia
authors.initials: P
authors.lastname: Laqua
authors.forename: Michael D
authors.initials: MD
authors.lastname: Jensen
authors.forename: John P
authors.initials: JP
authors.lastname: Bantle
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001786:Blood Glucose; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D015390:Gastric Bypass / Q000009:adverse effects; D006784:Hospitals, Teaching; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000627:therapeutic use; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications; D012307:Risk Factors; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D000959:Antihypertensive Agents; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D000960:Hypolipidemic Agents