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

• Main Authors: Aithal, G. (Author), Bergman, J.J.G.H.M (Author), Bhambhani, V. (Author), Bhatt, D.L (Author), Bisschops, R. (Author), Cercato, C. (Author), Chouhan, M.D (Author), Costamagna, G. (Author), Devière, J. (Author), Galvao Neto, M. (Author), Grecco, E. (Author), Haidry, R. (Author), Haji, A. (Author), Hayee, B. (Author), Hopkins, D. (Author), Lopez-Talavera, J.C (Author), Mingrone, G. (Author), Morris, A.J (Author), Moura, E. (Author), Rajagopalan, H. (Author), Repici, A. (Author), Sakai, N.S (Author), Sanyal, A.J (Author), Van Baar, A.C.G (Author), White, K. (Author)
• Format: Article
• Language: English
• Published: BMJ Publishing Group 2022
• Subjects: ablation therapy; adult; Adult; aged; Aged; Article; blood; body mass; Brazil; Brazilian; catheter ablation; Catheter Ablation; clinical effectiveness; clinical trial; controlled study; diabetes mellitus; Diabetes Mellitus, Type 2; double blind procedure; Double-Blind Method; duodenal mucosa; duodenum; Duodenum; endoscopic mucosal resection; Endoscopic Mucosal Resection; endoscopic procedures; Europe; European; fat content; fatty liver; Feasibility Studies; feasibility study; female; Female; glucose; glucose blood level; Glycated Hemoglobin A; glycemic control; glycosylated hemoglobin; hemoglobin A1c; hemoglobin A1c protein, human; human; Humans; hydrothermal duodenal mucosal resurfacing; Hyperthermia, Induced; Intestinal Mucosa; intestine mucosa; major clinical study; male; Male; metabolism; middle aged; Middle Aged; multicenter study; non insulin dependent diabetes mellitus; nonalcoholic fatty liver; nuclear magnetic resonance imaging; patient safety; randomized controlled trial; surgery; thermotherapy; treatment outcome; Treatment Outcome
• Online Access: View Fulltext in Publisher
• Physical Description: 11
• ISBN: 00175749 (ISSN)
• DOI: 10.1136/gutjnl-2020-323608

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/m 2, 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. ©