Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D): Study rationale, design, and methods
Year: 2022
Type: article
Abstract: Aims Long‐term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D) is a consortium of four randomized trials designed to compare long‐term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes. Materials and Methods Patients with T2D and body mass index (BMI) of 27‐45 kg/m 2 who were previously randomized to metabolic surgery (Roux‐en‐Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention in the STAMPEDE, SLIMM‐T2D, TRIABETES, or CROSSROADS trials have been enrolled in ARMMS‐T2D for observational follow‐up. The primary outcome is change in glycated haemoglobin after a minimum 7 years of follow‐up, with additional analyses to determine rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints. Results In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS‐T2D observational study. Participant demographics were 71% white, 27% African‐American and 68% female. At baseline: age, 50 ± 8 years; BMI, 36.5 ± 3.5 kg/m 2 ; duration of diabetes, 8.8 ± 5.6 years; glycated haemoglobin, 8.6% ± 1.6%; and fasting glucose, 168 ± 64 mg/dl. More than 35% of patients had a BMI <35 kg/m 2 . Conclusions ARMMS‐T2D will provide the largest body of long‐term, level 1 evidence to inform clinical decision‐making regarding the comparative durability, efficacy and safety of metabolic surgery relative to a medical/lifestyle intervention among patients with T2D, including those with milder class I obesity or mere overweight.
Source: Diabetes Obesity and Metabolism
DOI: 10.1111/dom.14680
Institutions: Brigham and Women's Hospital, Harvard University, Cleveland Clinic, Kaiser Permanente Washington Health Research Institute, Pennington Biomedical Research Center, University of Pittsburgh Medical Center, University of Washington, University of Washington Medical Center, Joslin Diabetes Center, AdventHealth Orlando, AdventHealth
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4214909788