Evidence mapPaperPMID 41657119Full record

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.

David N O'Neal, Adrian Sartoretto, Bronte A Holt, Barham K Abu Dayyeh, Rhys Vaughan, Georgina Cameron, Sujievvan Chandran, Alexander J Thompson, Howard McCollister, Paul Severson and 3 more

Abstract readClinical TrialMulticenter Study
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

David N O'NealDepartment of Medicine, St Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.ORCID https://orcid.org/0000-0002-0870-4032
Adrian SartorettoThe BMI Clinic, Double Bay, New South Wales, Australia.ORCID https://orcid.org/0000-0002-7444-4822
Bronte A HoltDepartment of Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia.
Barham K Abu DayyehDivision of Gastroenterology and Hepatology, Cedars-Senai Medical Center, Los Angeles, California, USA.
Rhys VaughanDepartment of Gastroenterology and Hepatology, Austin Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-4445-8000
Georgina CameronDepartment of Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-5800-2450
Sujievvan ChandranDepartment of Gastroenterology and Hepatology, Austin Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-5015-6287
Alexander J ThompsonDepartment of Medicine, St Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.ORCID https://orcid.org/0000-0001-9882-0071
Howard McCollisterMinnesota Institute for Minimally Invasive Surgery, Crosby, Minnesota, USA.
Paul SeversonMinnesota Institute for Minimally Invasive Surgery, Crosby, Minnesota, USA.
Andrew C StormWake Forest University School of Medicine, Winston-Salelm, North Carolina, USA.
Lian CunninghamEndogenex, Plymouth, Minnesota, USA.
Elif I EkinciAustralian Centre for Accelerating Diabetes Innovations, Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0003-2372-395X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Diabetes Mellitus, Type 2DuodenumElectric Stimulation TherapyAdolescentAdultAgedBlood GlucoseFeasibility StudiesFemaleGlycated HemoglobinHumansInsulin ResistanceMaleMiddle AgedProof of Concept StudyTreatment OutcomeBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humancontinuous glucose monitoring (CGM)duodenopathyendoscopyglycaemic controlpulsed electric field (PEF)type 2 diabetes (T2D)

Identifiers

PMID41657119
PMCPMC12992194

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.