Post written by Celine Busch, MD, and Annieke van Baar, MD, PhD, from Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

The duodenum has proven to play a crucial role in glucose homeostasis. It is thought that obesogenic diets cause certain alterations in the duodenal mucosa, eventually leading to metabolic syndrome and type 2 diabetes (T2D). Duodenal ablation to induce duodenal mucosal renewal has demonstrated beneficial effects on glycemia.

A novel technique for duodenal ablation is recellularization via electroporation therapy (ReCET). This single endoscopic procedure, performed with the patient under deep sedation and guided by fluoroscopy, uses electroporation to deliver controlled electric pulses through the mucosa. This process enhances permeability of the mucosa, in turn leading to natural cell death, or apoptosis of the treated cells. The process is repeated until 10 to 15 cm of the duodenum is treated.

This first-in-human, open-label study evaluates the feasibility, safety, and efficacy of ReCET combined with a glucagon-like peptide-1 receptor agonist (semaglutide) for eliminating exogenous insulin in patients with T2D.

Our findings indicate that ReCET is a feasible and safe endoscopic treatment. When combined with a glucagon-like peptide-1 receptor agonist, ReCET eliminated the need for insulin in 86% of patients while maintaining glycemic control (glycosylated hemoglobin ≤7.5%) and improving overall metabolic health at 6- and 12-month follow-up.

The impact of ReCET can be profound. The treatment is compliance-free, unlike drug therapy, which requires patients to take their medication day in and day out. Patient compliance is an important issue in management of T2D. In addition, the treatment is disease-modifying: It improves the patient’s sensitivity to their own (endogenous) insulin, thus tackling the root cause of the disease, as opposed to currently available drug therapies that are at best disease-controlling.

We are conducting a double-blind, randomized, sham-controlled study that follows the same inclusion and exclusion criteria as this trial. Patients are randomized to receive the ReCET procedure or a sham procedure, with all participants receiving semaglutide. This study also includes mechanistic assessments to evaluate the underlying mechanisms of ReCET, which are largely unknown.

A, Endogenex catheter, first generation. B, Endogenex catheter cone with flex circuit collapsed. C, Endogenex catheter cone with flex circuit expanded.

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