Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS‐T2D): Study rationale, design, and methods. Issue 7 (16th March 2022)

• Record Type: Journal Article
• Authors: Simonson, Donald C.; Hu, Bo; Arterburn, David E.; Schauer, Philip R.; Kashyap, Sangeeta R.; Courcoulas, Anita P.; Cummings, David E.; Patti, Mary‐Elizabeth; Gourash, William F.; Vernon, Ashley H.; Jakicic, John M.; Kirwan, John P.
• Is Part Of: Diabetes, obesity & metabolism. Volume 24:Issue 7(2022)
• Page Start: 1206
• Page End: 1215
• Publication Date: 2022-03-16
• Subjects: adjustable gastric band -- bariatric surgery -- clinical trial -- diabetes remission -- lifestyle -- metabolic surgery -- obesity -- Roux‐en‐Y gastric bypass -- sleeve gastrectomy -- type 2 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14680
• Languages: English
• ISSNs: 1462-8902

Abstract

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.