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

Abstract

Objective: 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 with medical/lifestyle management in patients with type 2 diabetes (NCT02328599).

Research design and methods: A total of 316 patients with type 2 diabetes previously randomly assigned 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. The primary outcome was the rate of diabetes remission (hemoglobin A1c [HbA1c] ≤6.5% for 3 months without usual glucose-lowering therapy) at 3 years. Secondary outcomes included glycemic control, body weight, biomarkers, and comorbidity reduction.

Results: Three-year data were available for 256 patients with mean 50 ± 8.3 years of age, 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 of 160 [37.5%] vs. 2 of 76 [2.6%], respectively; P < 0.001). Reductions in HbA1c (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 percentages of patients using medications to control diabetes, hypertension, and dyslipidemia were all lower after surgery (P < 0.001).

Conclusions: 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 I obesity, for whom surgery is not widely used.

Figure 1

CONSORT diagram. A total of 355 patients were previously randomly assigned into the parent trials, 39 of whom did not undergo intervention and were excluded from analysis. A total of 316 (N = 195 surgical and N = 121 medical/lifestyle) patients were assessed for eligibility and participation in the ARMMS-T2D trial. A total of 60 (N = 24 surgical and N = 36 medical/lifestyle) patients were excluded from analysis based upon missing HbA_1c values at 3 years. A total of 256 (N = 171 surgical and N = 85 medical/lifestyle) patients were included in analysis of primary and secondary outcomes.

Figure 2

Change in HbA_1c. A: Change in HbA_1c (%) from baseline to 12, 24, and 36 months following randomization to medical/lifestyle, RYGB, SG, or AGB. Least-squares means and corresponding SEs from a repeated-measures model are plotted. Black dotted line with black circles indicates combined effects of surgical intervention. Surgery lowered HbA_1c to a greater extent than medical/lifestyle intervention. B: Percent change in body weight from baseline to 12, 24, and 36 months following randomization to medical/lifestyle, RYGB, SG, or AGB. Least-squares means and corresponding SEs from a repeated-measures model are plotted. Black dotted line with black circles indicates combined effects of surgical intervention. Surgery lowered body weight to a greater extent than medical/lifestyle intervention. C: Percentage of patients taking diabetes medication at baseline and 3 years following surgery or medical/lifestyle intervention. LAGB, laparoscopic AGB.