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Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study)

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Annieke C.G. van Baar, Jacques Devière, David Hopkins, Laurent Crenier, Frits Holleman, Manoel P. Galvão Neto, Pablo Becerra, Paulina Vignolo, Leonardo Rodriguez Grunert, Geltrude Mingrone, Guido Costamagna, Max Nieuwdorp, Caterina Guidone, Rehan J. Haidry, Bu Hayee, Cormac Magee, Juan Carlos Lopez-Talavera, Kelly White, Vijeta Bhambhani, Emily Cozzi & 2 more Harith Rajagopalan, Jacques J.G.H.M. Bergman

Original languageEnglish
Article number109194
JournalDiabetes Research and Clinical Practice
Volume184
DOIs
PublishedFeb 2022

Bibliographical note

Funding Information: This study was supported by Fractyl Laboratories Inc. A.C.G.V.B., P.B., C.M., and P.V. have nothing to disclose. J.D. has received research support from Fractyl Laboratories Inc for IRB-approved studies. D.H. has received honorarium for consultancy and/or speaker fees from Novo Nordisk, Sanofi, Astra Zeneca, Roche, Sunovion, and Fractyl Laboratories Inc. L.C. has received honorarium for consultancy and/or speaker fees from Abbott, Astra Zeneca, Boehringer-Ingelheim, Eli Lilly, Medtronic, Novo Nordisk, and Sanofi. F.H. has received honorarium for consultancy from Bioton, Astra Zeneca, and Sanofi. M.P.G.N. has received honorarium for consultancy from Fractyl Laboratories Inc, GI Windows, GI Dynamics, and Apollo. He has participating in speaker bureaus for Ethicon, Medtronic, and Olympus. L.R.G. has nothing to disclose. G.M. has received funding/grant support from Novo Nordisk, Fractyl Laboratories Inc, Metacure, Keyron Ltd., and honorarium for consultancy from Johnson & Johnson, Novo Nordisk, and Fractyl Laboratories Inc. G.C. has received research grant support from Boston Scientific and Apollo and is on advisory boards for Cook Medical, Olympus, and Ethicon. M.N is on the scientific advisory board of Caelus health and Kaleido Bioscience. C.G. has nothing to disclose. R.J.H. has received funding/grant support/honorarium for consultancy from Cook Endoscopy, Pentax Europe, Medtronic, C2 Therapeutics, and Fractyl Laboratories Inc to support research infrastructure. BH has nothing to disclose. H.R., J.C.L-T., K.W., V.B., and E.C. are full-time employees of Fractyl Laboratories Inc and may hold Fractyl stock and/or stock options. J.J.G.H.M.B. has received research support from Fractyl Laboratories Inc for IRB-based studies and has received a consultancy fee for a single advisory board meeting for Fractyl Laboratories Inc in September 2019.]. Publisher Copyright: © 2022 The Authors

King's Authors

Abstract

Aims: Duodenal mucosal resurfacing (DMR) is an endoscopic procedure developed to improve metabolic parameters and restore insulin sensitivity in patients with diabetes. Here we report long-term DMR safety and efficacy from the REVITA-1 study. Materials and Methods: REVITA-1 was a prospective, single-arm, open-label, multicenter study of DMR feasibility, safety, and efficacy in patients with type 2 diabetes (hemoglobin A1c [HbA1c] of 7.5–10.0% (58–86 mmol/mol)) on oral medication. Safety and glycemic (HbA1c), hepatic (alanine aminotransferase [ALT]), and cardiovascular (HDL, triglyceride [TG]/HDL ratio) efficacy parameters were assessed (P values presented for LS mean change). Results: Mean ± SD HbA1c levels reduced from 8.5 ± 0.7% (69.1 ± 7.1 mmol/mol) at baseline (N = 34) to 7.5 ± 0.8% (58.9 ± 8.8 mmol/mol) at 6 months (P < 0.001); and this reduction was sustained through 24 months post-DMR (7.5 ± 1.1% [59.0 ± 12.3 mmol/mol], P < 0.001) while in greater than 50% of patients, glucose-lowering therapy was reduced or unchanged. ALT decreased from 38.1 ± 21.1 U/L at baseline to 32.5 ± 22.1 U/L at 24 months (P = 0.048). HDL and TG/HDL improved during 24-months of follow-up. No device- or procedure-related serious adverse events, unanticipated device effects, or hypoglycemic events were noted between 12 and 24 months post-DMR. Conclusions: DMR is associated with durable improvements in insulin sensitivity and multiple downstream metabolic parameters through 24 months post-treatment in type 2 diabetes. Clinical trial reg. no. NCT02413567, clinicaltrials.gov.

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