For individuals with type 2 diabetes, metabolic bariatric surgery is more effective at improving A1C, weight loss, diabetes remission, glycemic management, and using fewer diabetes medications for up to 12 years compared to intensive medical and lifestyle management. Results of the Alliance of Randomized Trials of Medical Management vs. Metabolic Surgery for Type 2 Diabetes (ARMMS-T2D) trial showed significant benefits for Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric band versus intensive medical/lifestyle management.

“Metabolic surgery improves diabetes-related outcomes more than medical/lifestyle treatment for individuals with type 2 diabetes,” said Anita Courcoulas, MD, MPH, the Anthony M. Harrison Professor of Surgery, University of Pittsburgh. “These improvements followed the same pattern in the subgroup of participants who had class 1 obesity with a BMI (body mass index) less than 35.”

Dr. Courcoulas revealed the primary and secondary results of ARMMS-T2D trial during Is Metabolic Surgery or Lifestyle/Medical Management of Type 2 Diabetes Optimal for Long-Term Health? Long-Term Outcomes of the ARMMS-T2D Randomized Trial after 7-12 Years of Follow-Up. The session can be viewed on-demand by registered meeting participants at ADA2023.org. If you haven’t registered for the 83rd Scientific Sessions, register today to access the valuable meeting content through August 28.

ARMMS-T2D was a prospective, observational follow-up to four randomized trials comparing metabolic surgery and medical management between 2007 and 2013: STAMPEDE, based at the Cleveland Clinic; SLIMM-T2D at Brigham and Women’s Hospital and Joslin Diabetes Center; TRIABETES at the University of Pittsburgh; and CROSSROADS at the University of Washington. The parent trials randomized 355 participants with type 2 diabetes to either intensive medical and weight management for at least a year plus continuing care with currently available medications and lifestyle support or to metabolic bariatric surgery.

“Before ARMMS-T2D, we knew that bariatric surgery is the most effective and durable intervention for weight loss in class 3 obesity, but the obesity trials were not randomized and were not reflective of the populations we see in diabetes clinic,” said Sangeeta Kashyap, MD, Professor of Medicine and Assistant Chief of Clinical Affairs, Weill Cornell Medical Center. Dr. Kashyap was one of the original ARMMS-T2D collaborators at Cleveland Clinic.

“About 40% of ARMMS-T2D participants had class 1 obesity with a BMI less than 35,” she continued. “The parent trials all showed greater glycemic control and diabetes remission with surgery, but they were relatively short term. The clinical challenge has always been to maintain weight loss for longer-term clinical benefit.”

Of the original parent trial participants, 186 from the metabolic surgical arm and 96 from the medical/lifestyle arm enrolled in ARMMS-T2D. All were followed at least seven years. Annual visits included BMI, waist circumference, and blood pressure measurement; blood and urine tests; medications; diabetes complications; renal and cardiovascular events; quality of life; and adverse events.

Data presented at the 83rd Scientific Sessions included both seven- and 12-year results with safety data out to 15 years, noted Mary-Elizabeth Patti, MD, Director of the Hypoglycemia Clinic and Co-Director of the Molecular Phenotyping and Genotyping Core, Joslin Diabetes Center, and Associate Professor of Medicine, Harvard Medical School.

The primary outcomes were between-group differences in A1C at seven years for all participants and up to 12 years for early enrollees. Secondary outcomes included change in A1C, diabetes remission, and between-group differences in weight, BMI, lipids, blood pressure, diabetes medication usage, major adverse cardiovascular events (MACE), and other adverse events.

At seven years, the medical/lifestyle arm had a mean A1C of 8.2% versus 7.2% for the surgical group. Results at 12 years were similar, 8% and 7.3%, respectively.

Diabetes remission, defined as A1C less than 6.5% without medications, was 6.2% for the medical/lifestyle arm at seven years versus 18.2% for the surgical arm. At 12 years, none of the medical/lifestyle participants were in remission versus 12.7% of surgery participants.

Glycemic management with an A1C less than 7% was superior with surgery—27% versus 54% at seven years and 29% versus 55% for medical/lifestyle and surgery participants, respectively.

The medical/lifestyle group lost 8.3% of initial body weight at seven years versus 19.9% for surgery and 10.8% versus 19.3% at 12 years.

Metabolic surgery had increased risk for anemia, fractures, and gastrointestinal symptoms.

“Clinicians should consider metabolic surgery as an option to improve diabetes-related outcomes, including for people with BMI less than 35,” Dr. Courcoulas said.