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

• Published in: Diabetes research and clinical practice Vol. 184; p. 109194
• Main Authors: van Baar, Annieke C.G., Devière, Jacques, Hopkins, David, Crenier, Laurent, Holleman, Frits, Galvão Neto, Manoel P., Becerra, Pablo, Vignolo, Paulina, Rodriguez Grunert, Leonardo, Mingrone, Geltrude, Costamagna, Guido, Nieuwdorp, Max, Guidone, Caterina, Haidry, Rehan J., Hayee, Bu, Magee, Cormac, Carlos Lopez-Talavera, Juan, White, Kelly, Bhambhani, Vijeta, Cozzi, Emily, Rajagopalan, Harith, J.G.H.M. Bergman, Jacques
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01-02-2022
• Subjects: Blood Glucose - metabolism; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - surgery; Duodenal mucosal resurfacing; Duodenum; Duodenum - chemistry; Duodenum - metabolism; Duodenum - surgery; Endoscopic ablation; Glycated Hemoglobin A - analysis; Humans; Hypoglycemic Agents - therapeutic use; Prospective Studies; Treatment Outcome; Type 2 diabetes mellitus; Endoscopic ablation; Type 2 diabetes mellitus; Duodenum; Duodenal mucosal resurfacing
• ISSN: 0168-8227; 1872-8227
• DOI: 10.1016/j.diabres.2022.109194

•We demonstrate long-term safety and tolerability of DMR in patients with T2D.•HbA1c was significantly reduced at 24 months post-DMR.•Over 50% of patients reduced or kept their glucose lowering medications constant.•Insulin resistance, a known pathological driver of T2D, improved after single DMR.•We observed additional positive effects on metabolic disturbances in T2D post-DMR.
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.
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).
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.
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.