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

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posted on 24.03.2022, 21:25 by John P. Kirwan, Anita P. Courcoulas, David E. Cummings, Allison B. Goldfine, Sangeeta R. Kashyap, Donald C. Simonson, David E. Arterburn, William F. Gourash, Ashley H. Vernon, John M. Jakicic, Mary Elizabeth Patti, Kathy Wolski, Philip R. Schauer
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 to medical/lifestyle management in patients with type 2 diabetes (NCT02328599).

RESEARCH DESIGN AND METHODS: 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. The primary outcome was the rate of diabetes remission (hemoglobin A1c (HbA1c) ≤6.5% for 3 months without usual glucose-lowering therapy) at three years. Secondary outcomes included glycemic control, body weight, biomarkers, and comorbidity reduction.

RESULTS: 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 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 percentage 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 1 obesity, for whom surgery is not widely used.

Funding

This research was primarily supported by an investigator-initiated grant from Ethicon Endo-Surgery and Medtronic, and by in-kind support from Lifescan and Novo Nordisk.

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