The study seeks to answer several questions that look at which patients benefit from surgery over the long term.
Studies have shown that bariatric surgery can reverse type 2 diabetes (T2D) in some obese people, but which ones benefit the most?
That’s what a study set to start in July 2017 seeks to find out. In the process, investigators want to answer several questions: do only those who are severely obese gain health benefits, or do those who are moderately obese benefit as well? Do health gains last? And, does surgery change the risk of complications from diabetes?
Cleveland Clinic, which recently published the 5-year results of the STAMPEDE study, which showed bariatric surgery with medication was better than medication alone in controlling T2D, is coordinating the ARMMS-T2D study, which stands for Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes. Other centers taking part are Joslin Diabetes Center, the University of Pittsburgh, and the University of Washington.
About 242 patients with T2D will take part in the study, including a third who have a body mass index of less than 35 kg/m2.
ARMMS-T2D is a follow-up from 4 earlier trials known as SLIMM-T2D (Surgery or Lifestyle with Intensive Medical Management in the Treatment of Type 2 Diabetes), which took place at Joslin and Brigham and Women’s Hospital. Data from those trials will be merged into this new study to follow these patients, giving researchers the largest group of study patients followed over a long period of time.
Leading the research team at Joslin is Mary-Elizabeth Patti, MD, FACP, director of Joslin's hypoglycemia clinic. For the next 5 years, participants will periodically give blood samples, which Patti and her researchers will measure for hormone secretions. “The 4 centers came together so we could pool the studies to get more information about how surgery changes metabolism in the long term,” she said in a statement. “We know that’s the case in the short run, and that it’s better than medical management alone, but we want to understand how surgery controls diabetes and if it does so for the long term.”