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

Author:

Kirwan John P.12ORCID,Courcoulas Anita P.3,Cummings David E.45,Goldfine Allison B.67,Kashyap Sangeeta R.1,Simonson Donald C.78,Arterburn David E.9,Gourash William F.3,Vernon Ashley H.78,Jakicic John M.10,Patti Mary Elizabeth67,Wolski Kathy1,Schauer Philip R.12

Affiliation:

1. 1Cleveland Clinic, Cleveland, OH

2. 2Pennington Biomedical Research Center, Baton Rouge, LA

3. 3University of Pittsburgh Medical Center, Pittsburgh, PA

4. 4University of Washington, Seattle, WA

5. 5VA Puget Sound Health Care System, Seattle, WA

6. 6Joslin Diabetes Center, Boston, MA

7. 7Harvard Medical School, Boston, MA

8. 8Brigham and Women’s Hospital, Boston, MA

9. 9Kaiser Permanente Washington Health Research Institute, Seattle, WA

10. 10AdventHealth Research Institute, Orlando, FL

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.

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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