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Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D): Study rationale,

Donald C Simonson1,2, Bo Hu3, David E Arterburn4

  • 1Brigham and Women's Hospital, Boston, Massachusetts, USA.

Diabetes, Obesity & Metabolism
|March 2, 2022
PubMed
Abstract

Insights

Long-term data comparing bariatric surgery to medical interventions for type 2 diabetes (T2D) is limited. The ARMMS-T2D study provides crucial long-term evidence on the efficacy and safety of metabolic surgery versus lifestyle changes for T2D management.

Area of Science:

  • Endocrinology and Metabolism
  • Bariatric Surgery
  • Type 2 Diabetes Management

Background:

  • Limited long-term data exists comparing metabolic (bariatric) surgery with medical/lifestyle interventions for type 2 diabetes (T2D).
  • The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) was established to address this gap.
  • This consortium aims to evaluate the long-term efficacy and safety of surgical versus non-surgical approaches for T2D.

Purpose of the Study:

  • To compare the long-term efficacy and safety of metabolic surgery against medical/lifestyle interventions in patients with T2D.
  • To assess the durability of diabetes control, including changes in glycated hemoglobin, and rates of remission and relapse.
  • To evaluate cardiovascular and renal outcomes following surgical versus non-surgical T2D treatment.

Main Methods:

  • Observational follow-up of patients previously randomized in four trials (STAMPEDE, SLIMM-T2D, TRIABETES, CROSSROADS).
  • Participants had T2D and a BMI between 27-45 kg/m².
  • Primary outcome: change in glycated hemoglobin after a minimum of 7 years; secondary outcomes include diabetes remission/relapse and clinical endpoints.

Main Results:

  • 302 patients (192 surgical, 110 medical/lifestyle) were enrolled in the ARMMS-T2D observational study.
  • Baseline characteristics included a mean age of 50 years, BMI of 36.5 kg/m², and diabetes duration of 8.8 years.
  • Notably, over 35% of patients had a BMI below 35 kg/m², indicating inclusion of individuals with Class I obesity or overweight.

Conclusions:

  • ARMMS-T2D will generate substantial long-term, level 1 evidence on metabolic surgery versus medical/lifestyle interventions for T2D.
  • Findings will inform clinical decisions regarding the comparative effectiveness and safety of these treatment modalities.
  • The study includes diverse patient populations, including those with milder obesity, to provide broader applicability.
Keywords:
Roux-en-Y gastric bypassadjustable gastric bandbariatric surgeryclinical trialdiabetes remissionlifestylemetabolic surgeryobesitysleeve gastrectomytype 2 diabetes

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