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

摘要: Importance Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. Objective To test the feasibility methods to conduct larger multisite trial determine long-term effect Roux-en-Y gastric bypass (RYGB) compared with an intensive medical and weight (Weight Achievement Intensive Treatment [Why WAIT]) program diabetes. Design, Setting, Participants A 1-year pragmatic randomized clinical was conducted in academic institution. included persons aged 21 65 years diagnosed more than 1 year before study; their body mass index 30 42 (calculated kilograms divided by height meters squared) hemoglobin 1c (HbA ) greater or equal 6.5%. All participants were receiving antihyperglycemic medications. Interventions RYGB (n = 19) Why WAIT including 12 weekly multidisciplinary group lifestyle, medical, educational sessions monthly follow-up thereafter. Main Outcomes Measures Proportion patients fasting plasma glucose levels less 126 mg/dL HbA 6.5%, measures cardiometabolic health, patient-reported outcomes. Results At year, proportion achieving below 6.5% higher following (58% vs 16%, respectively; P  = .03). Other outcomes, , weight, waist circumference, fat mass, lean blood pressure, triglyceride levels, decreased high-density lipoprotein cholesterol increased after WAIT. Improvement cardiovascular risk scores surgical group. baseline exhibited moderately low self-reported quality-of-life reflected Short Form-36 total, physical mental well high Impact Weight on Quality Life–Lite Problem Areas Diabetes health status scores. improvements did not differ significantly between groups. The score improved correlated loss Conclusions Relevance In obese diabetes, produces sustained factors management, emergent differences over year. Both treatments improve general measures, but provides improvement quality life. These may help inform decisions strategies until trials are performed. Trial Registration clinicaltrials.gov Identifier:NCT01073020