Diabetes Remission in the Alliance of Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D)

<b>OBJECTIVE:</b> The overall aim of the Alliance of Randomized Trials of Medicine versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) consortium is to assess the durability and longer-term effectiveness of metabolic surgery compared to medical/lifestyle management in patients with type 2 diabetes (NCT02328599). <p><b>RESEARCH DESIGN AND METHODS: </b>316 patients with type 2 diabetes previously randomized to surgery (N=195) or medical/lifestyle therapy (N=121) in the STAMPEDE, TRIABETES, SLIMM-T2D and CROSSROADS trials were enrolled into this prospective observational cohort. <a>The primary outcome was the rate of diabetes remission (hemoglobin A1c (HbA_1c) ≤6.5% for 3 months without usual glucose-lowering therapy) at three years. Secondary outcomes included glycemic control, body weight, biomarkers, and comorbidity reduction.</a></p> <p><b>RESULTS:</b> Three-year data were available for 256 patients with mean age 50±8.3 years, BMI 36.5±3.6 kg/m² and duration of diabetes 8.8±5.7 years. Diabetes remission was achieved in more participants following surgery than medical/lifestyle intervention (60/160 (37.5%) vs. 2/76 (2.6%), respectively, p<0.001). Reductions in HbA_1c (Δ = -1.9±2.0 vs. -0.1±2.0%, p<0.001), fasting plasma glucose (Δ = -52[-105, -5] vs. -12[-48, 26] mg/dL, p<0.001) and BMI (Δ = -8.0±3.6 vs. -1.8±2.9 kg/m², p<0.001) were also greater after surgery. The percentage of patients using medications to control diabetes, hypertension, and dyslipidemia were all lower after surgery (p<0.001). </p> <b>CONCLUSIONS:</b> Three-year follow-up of the largest cohort of randomized patients followed to date demonstrates that metabolic/bariatric surgery is more effective and durable than medical/lifestyle intervention in remission of type 2 diabetes, including among individuals with class 1 obesity, for whom surgery is not widely used.