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

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

Risultato della ricerca: Contributo in rivistaArticolo in rivista

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.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
RivistaDiabetes Research and Clinical Practice
Volume184
DOI
Stato di pubblicazionePubblicato - 2022

Keywords

  • Duodenal mucosal resurfacing
  • Duodenum
  • Endoscopic ablation
  • Type 2 diabetes mellitus
  • Blood Glucose
  • Diabetes Mellitus, Type 2
  • Glycated Hemoglobin A
  • Humans
  • Hypoglycemic Agents
  • Prospective Studies
  • Treatment Outcome

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