RT Journal Article SR Electronic 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 FD BMJ Publishing Group Ltd and British Society of Gastroenterology SP 254 OP 264 DO 10.1136/gutjnl-2020-323608 VO 71 IS 2 A1 Geltrude Mingrone A1 Annieke CG van Baar A1 Jacques Devière A1 David Hopkins A1 Eduardo Moura A1 Cintia Cercato A1 Harith Rajagopalan A1 Juan Carlos Lopez-Talavera A1 Kelly White A1 Vijeta Bhambhani A1 Guido Costamagna A1 Rehan Haidry A1 Eduardo Grecco A1 Manoel Galvao Neto A1 Guruprasad Aithal A1 Alessandro Repici A1 Bu'Hussain Hayee A1 Amyn Haji A1 A John Morris A1 Raf Bisschops A1 Manil D Chouhan A1 Naomi S Sakai A1 Deepak L Bhatt A1 Arun J Sanyal A1 J J G H M Bergman A1 , YR 2022 UL http://gut.bmj.com/content/71/2/254.abstract AB 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 NCT02879383Data are available upon reasonable request.