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

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Geltrude Mingrone 1, Simona Panunzi 2, Andrea De Gaetano 2, Caterina Guidone 3, Amerigo Iaconelli 3, Esmeralda Capristo 3, Ghassan Chamseddine 4, Stefan R Bornstein 5, Francesco Rubino 6

Main idea: Metabolic surgery is more effective than conventional medical therapy in the long-term control of type 2 diabetes. Clinicians and policy makers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes.

Abstract

Background: No data from randomised controlled trials of metabolic surgery for diabetes are available beyond 5 years of follow-up. We aimed to assess 10-year follow-up after surgery compared with medical therapy for the treatment of type 2 diabetes.

Methods: We did a 10-year follow-up study of an open-label, single-centre trial in Rome, Italy. Patients with type 2 diabetes were randomly assigned to gastric bypass or biliopancreatic diversion. The primary endpoint was diabetes remission at 2 years without ongoing medication. In the analysis, durability of diabetes remission was analysed by intention to treat (ITT) . This study is registered with ClinicalTrials.gov, NCT00888836.

Findings: Between April 30, 2009, and Oct 31, 2011, of 72 patients assessed for eligibility, 60 were included. The 10-year follow-up rate was 95·0% (57 of 60). Of all patients who were surgically treated, 15 (37·5%) maintained diabetes remission throughout the 10-year period. 10-year remission rates in the ITT population were 5 5% for medical therapy and 50% for BPD. Serious adverse events occurred more frequently among participants in the BPD group. Participants in the RYGB and BPD groups had fewer diabetes-related complications than those in the medical therapy group.

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