Diabetes, obesity & metabolism · 2026
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.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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O'Neal David N, Sartoretto Adrian, Holt Bronte A, Abu Dayyeh Barham K, Vaughan Rhys, Cameron Georgina, Chandran Sujievvan, Thompson Alexander J, McCollister Howard, Severson Paul, Storm Andrew C, Cunningham Lian, Ekinci Elif I
Аннотация
AIMS: The 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 METHODS: An 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/m2 and glycated haemoglobin (HbA1c) 7.5%-11.0% (58-97 mmol/mol). Participants underwent endoscopic, catheter-based PEF therapy to the duodenal wall (600 or 750 V, single or double application) and were followed for 48 weeks. The primary endpoint was the incidence of device- or procedure-related serious adverse events (SAEs).
RESULTS: No 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.
CONCLUSIONS: PEF-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.
MATERIALS AND METHODS: An 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/m2 and glycated haemoglobin (HbA1c) 7.5%-11.0% (58-97 mmol/mol). Participants underwent endoscopic, catheter-based PEF therapy to the duodenal wall (600 or 750 V, single or double application) and were followed for 48 weeks. The primary endpoint was the incidence of device- or procedure-related serious adverse events (SAEs).
RESULTS: No 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.
CONCLUSIONS: PEF-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.