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

Autor: van Baar ACG; Gastroenterology and Hepatology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands., Devière J; Gastroenterology, Erasme UnCiversity Hospital, Brussels, Belgium., Hopkins D; Institute of Diabetes, Endocrinology, and Obesity, King's Health Partners, London, UK., Crenier L; Department of Endocrinology, Erasme University Hospital, Brussels, Belgium., Holleman F; Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands., Galvão Neto MP; Bariatric Endoscopy Service, Gastro Obeso Center, Sao Paulo, Brazil., Becerra P; CCO Clinical Center for Diabetes, Obesity and Reflux, Santiago, Chile., Vignolo P; CCO Clinical Center for Diabetes, Obesity and Reflux, Santiago, Chile., Rodriguez Grunert L; CCO Clinical Center for Diabetes, Obesity and Reflux, Santiago, Chile., Mingrone G; Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy; Department of Diabetes, School of Life Course Sciences, King's College London, London, UK., Costamagna G; Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy., Nieuwdorp M; Internal and Vascular Medicine, Amsterdam University Medical Centers, location AMC, Amsterdam, the Netherlands., Guidone C; Internal Medicine, Fondazione Policlinico A. Gemelli IRCSS, Rome, Italy., Haidry RJ; Department of Gastroenterology, University College Hospital, London, UK., Hayee B; Institute of Diabetes, Endocrinology, and Obesity, King's Health Partners, London, UK., Magee C; Department of Gastroenterology, University College Hospital, London, UK; Center for Obesity Research, Department of Medicine, University College London, London, UK., Carlos Lopez-Talavera J; Fractyl Laboratories Inc, Lexington, MA, USA., White K; Fractyl Laboratories Inc, Lexington, MA, USA., Bhambhani V; Fractyl Laboratories Inc, Lexington, MA, USA., Cozzi E; Fractyl Laboratories Inc, Lexington, MA, USA., Rajagopalan H; Fractyl Laboratories Inc, Lexington, MA, USA., J G H M Bergman J; Gastroenterology and Hepatology, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, the Netherlands. Electronic address: j.j.bergman@amsterdamumc.nl.
Jazyk: angličtina
Zdroj: Diabetes research and clinical practice [Diabetes Res Clin Pract] 2022 Feb; Vol. 184, pp. 109194. Date of Electronic Publication: 2022 Jan 13.
DOI: 10.1016/j.diabres.2022.109194
Abstrakt: 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.
(Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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