Trial reportDiabetes, obesity & metabolism2026
Safety, feasibility, and dose-dependent metabolic effects of endoscopic duodenal pulsed electric field therapy in adults with type 2 diabetes: Results from two multicentre proof-of-concept studies.
Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
13 authors.
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Abstract
aimsThe duodenum plays a central role in metabolic regulation, influencing insulin sensitivity, and glucose homeostasis. In type 2 diabetes (T2D), structural and functional abnormalities of the duodenal mucosa ("diabetic duodenopathy") are increasingly recognized as contributors to insulin resistance and dysglycaemia. Non-thermal duodenal cellular regeneration using pulsed electric field (PEF) therapy offers a novel approach to restore metabolic signalling and target the underlying pathophysiology of T2D. MATERIALS AND
methodsAn integrated analysis of two parallel, open-label, multicentre feasibility studies evaluated the safety, feasibility, and metabolic effects of PEF-based duodenal therapy in adults with uncontrolled T2D treated with non-insulin medications. Eligible participants (n = 71) were 18-70 years old, with body mass index 24-40 kg/m
resultsNo device- or procedure-related SAEs were reported, demonstrating a favourable safety profile. Higher-energy dosing, double applications, and use of the second-generation catheter yielded greater and sustained metabolic improvements through 48 weeks, including reductions in HbA1c, fasting glucose, weight, and markers of insulin resistance. Continuous glucose monitoring showed sustained increases in time-in-range and reduced glycaemic variability.
conclusionsPEF-based duodenal regeneration therapy was safe, technically feasible, and associated with durable metabolic improvements over 48 weeks. These findings support further evaluation of duodenal electroporation as a novel, minimally invasive approach for managing T2D.
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