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

Geltrude Mingrone, Annieke C.G. Van Baar, Jacques Devière, David Hopkins, Eduardo Moura, Cintia Cercato, Harith Rajagopalan, Juan Carlos Lopez-Talavera, Kelly White, Vijeta Bhambhani, Guido Costamagna, Rehan Haidry, Eduardo Grecco, Manoel Galvao Neto, Guruprasad Aithal, Alessandro Repici, Bu'Hussain Hayee, Amyn Haji, A. John Morris, Raf BisschopsManil D. Chouhan, Naomi S. Sakai, Deepak L. Bhatt, Arun J. Sanyal, J. J.G.H.M. Bergman

Research output: Contribution to journalArticlepeer-review

69 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)254-264
Number of pages11
JournalGut
Volume71
Issue number2
DOIs
StatePublished - 1 Feb 2022
Externally publishedYes

Keywords

  • diabetes mellitus
  • duodenal mucosa
  • endoscopic procedures
  • fatty liver

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