Duodenal Mucosal Resurfacing Elicits Improvement in Glycemic and Hepatic Parameters in Type 2 Diabetes—One-Year Multicenter Study Results

Abstract

Aims: Duodenal Mucosal Resurfacing (DMR) is a novel endoscopic procedure which has been shown to improve glycemic control at 6 months in type 2 diabetes (T2D). It is thought to exert insulin-sensitizing effects. DMR entails catheter based circumferential mucosal lifting followed by hydrothermal ablation. This study aimed to extend DMR experience, determining efficacy over 12 months in T2D patients on stable oral glucose lowering treatment. Methods: Single arm, multicenter study. 46 T2D patients on oral glucose lowering medication received a DMR procedure. Impact on glycemic control (HbA1c and fasting plasma glucose), insulin resistance (HOMA-IR) and liver enzymes (AST and ALT) was determined at baseline and 1, 3, 6, 9, 12 mo post DMR. Glucose lowering medication was kept stable 6 mo post DMR and adjusted according to local guidelines thereafter. Results: See figure 1. At 12 mo: δHbA1c -1.0±0.2% (p ≤ 0.001), δFPG -41±8 mg/dL (p ≤ 0.001), δHOMA-IR -3.6±0.9 (p = 0.005), δ weight -2.7±0.6kg (p = 0.003), δALT -10±2 (p = 0.005) and δAST -6±2 (p=0.002). DMR was well tolerated with no related serious adverse events or unexpected adverse device events reported. Conclusions: Single DMR treatment elicited significant and clinically relevant reductions in glycemic and hepatic parameters that were sustained at 12 months, suggesting considerable potential of DMR for the treatment of T2D. Disclosure A.C.G. van Baar: None. M. Nieuwdorp: None. F. Holleman: Other Relationship; Self; Sanofi-Aventis, Bioton, AstraZeneca. J. Deviere: None. L. Crenier: None. R. Haidry: None. R.L. Batterham: Research Support; Self; Fractyl Laboratories, Inc.. Board Member; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; National Institute for Health and Clinical Excellence, Nestlé. Speaker's Bureau; Self; Orexigen Therapeutics, Inc., Medtronic. D. Hopkins: Advisory Panel; Self; Novo Nordisk A/S, Sanofi-Aventis, Roche Pharma. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Napp Pharmaceuticals, Ltd., Sunovion Pharmaceuticals Inc.. Other Relationship; Self; Diabetes UK. Speaker's Bureau; Self; Fractyl Laboratories, Inc.. L. Rodriguez Grunert: None. M. Galvao Neto: Consultant; Self; Fractyl Laboratories, Inc., GI Dynamics Inc., GI Windows, Inc., Ethicon US, LLC., Apollo EndoSurgery. P. Vignolo: None. G. Costamagna: None. J.J. Bergman: Research Support; Self; Fractyl Laboratories, Inc..