TY - JOUR T1 - Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial JF - Gut JO - Gut DO - 10.1136/gutjnl-2020-323608 SP - gutjnl-2020-323608 AU - Geltrude Mingrone AU - Annieke CG van Baar AU - Jacques Devière AU - David Hopkins AU - Eduardo Moura AU - Cintia Cercato AU - Harith Rajagopalan AU - Juan Carlos Lopez-Talavera AU - Kelly White AU - Vijeta Bhambhani AU - Guido Costamagna AU - Rehan Haidry AU - Eduardo Grecco AU - Manoel Galvao Neto AU - Guruprasad Aithal AU - Alessandro Repici AU - Bu'Hussain Hayee AU - Amyn Haji AU - A John Morris AU - Raf Bisschops AU - Manil D Chouhan AU - Naomi S Sakai AU - Deepak L Bhatt AU - Arun J Sanyal AU - J J G H M Bergman A2 - , Y1 - 2021/02/17 UR - http://gut.bmj.com/content/early/2021/03/02/gutjnl-2020-323608.abstract N2 - Objective Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D).Design Eligible patients (haemoglobin A1c (HbA1c) 59–86 mmol/mol, body mass index≥24 and ≤40 kg/m2, fasting insulin >48.6 pmol/L, ≥1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks.Results Overall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was −10.4 (18.6) mmol/mol in DMR group versus −7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was −5.4 (5.6)% in DMR group versus −2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was –6.6 mmol/mol (17.5 mmol/mol) versus –3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was –5.4% (6.1%) versus –2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient.Conclusions DMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG.Trial registration number NCT02879383 ER -