Ten-year follow-up data in patients with type 2 diabetes show better outcomes in those undergoing metabolic surgery, compared to conventional medical therapy, reports a study in The Lancet.
The researchers analyzed data from a previous open-label, single-center trial in which 60 obese patients with type 2 diabetes were randomly assigned to medical therapy, Roux-en-Y gastric bypass (RYGB), or biliopancreatic diversion (BPD). The main outcome of interest was diabetes remission, defined as glycated hemoglobin less than 6.5% with a fasting blood glucose level of less than 5.5 mmol and no diabetes medications for at least 1 year. Fifty-seven patients were available for long-term follow-up.
On intention-to-treat analysis, 10-year remission rates were 50.0% in the BPD group, 25.0% in the RYGB group, and 5.5% in the medical therapy group. One patient initially assigned to medical therapy achieved remission after crossing over to surgery. Overall, type 2 diabetes remained in remission throughout a 10-year follow-up in 37.5% of patients who had either form of metabolic surgery.
Of the 34 patients whose diabetes was in remission at 2 years, 20 had a relapse of hyperglycemia during follow-up. Relapse rates were 52.6% in the BPD group and 66.7% in the RYGB group. However, all patients with relapse had adequate glycemic control at 10 years. Risk of diabetes-related complications was substantially lower in the two metabolic surgery groups: relative risk 0.07. Compared to patients receiving medical therapy, serious adverse events were more frequent in the BPD group (odds ratio 2.7) and less frequent in the RYGB group (odds ratio 0.7).
Bariatric or metabolic surgery has become an established treatment for type 2 diabetes, with clinical trials showing prolonged remission and reductions in cardiometabolic and chronic kidney disease risks, among other benefits. The new report presents the first randomized trial data on outcomes of metabolic surgery for diabetes beyond a 5-year follow-up.
The results add further support to the effectiveness of metabolic surgery over conventional medical therapy for long-term control of type 2 diabetes. The investigators conclude, “Clinicians and policy makers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes” [Mingrone G, et al. Metabolic surgery versus conventional medical therapy in patients with type 2 diabetes: 10-year follow-up of an open-label, single-centre, randomised controlled trial. Lancet 2021; 397:293–304. doi: 10.1016/S0140-6736(20)32649-0; https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32649-0/fulltext].