Background: Duodenal dysfunction, specifically in nutrient sensing, iron homeostasis, and inflammation is linked to Type 2 Diabetes. This study assesses Endoscopic Re-Cellularization via Electroporation Therapy (ReCET™), an outpatient procedure using non-thermal pulsed electric field to regenerate the duodenal function.
Methods: Participants (18-70 years, BMI 24-40 kg/m², HbA1c 7.5%-11.0%, on 1-4 non-insulin antidiabetics) received PEF. Primary endpoints were serious adverse events at 12 weeks, with secondary endpoints including efficacy and response predictors at 24 weeks.
Results: 71 patients (age 55, 73% male, BMI 31.7 kg/m², T2D duration 5.8 years, baseline HbA1c 8.6%) participated. Treatment groups received either low or high energy doses. No SAEs occurred. The high energy group exhibited significant glycemic improvement (-1.11 HbA1c reduction vs. -0.32 in low energy group, p=0.015) and improved Time in Range, %TBWL, HOMA-IR, Triglyceride, and Ferritin. Baseline Ferritin and HbA1c were predictors of response (figure 1). Subgroup with baseline Ferritin ≥200 and HbA1c ≥8 showed a -2.04 [95%CI -3.94, -0.14] HbA1c reduction at 24 weeks with high energy.
Conclusions: ReCET™ enhances glycemic control in T2D without SAEs, impacting weight, lipid profile, and iron metabolism. This suggests a novel mechanism complementing existing T2D treatments.
B.K. Abu Dayyeh: Research Support; USGI Medical, Apollo Endosurgery. Consultant; Boston Scientific Corporation, Medtronic. Other Relationship; Endogenex. Research Support; ERBE. A. Sartoretto: Research Support; Endogenex, Erbe Electromedizin GmbH. Advisory Panel; Bariatek. Consultant; Boston Scientific Corporation, Intuitive Surgical. A.C. Storm: Consultant; Intuitive Surgical, Boston Scientific Corporation, Olympus. Research Support; Apollo Endosurgery, Endogenex, Microtech. Consultant; Enterasense. Research Support; OnePass. H.M. McCollister: Consultant; Endogenex. P.A. Severson: Consultant; Endogenex. B. Holt: None. G. Cameron: None. R. Vaughan: None. J. Lipham: Consultant; Endogenex, Ethicon, Inc., Implantica. E.I. Ekinci: Advisory Panel; Lilly Diabetes. Research Support; Novo Nordisk, Boehringer-Ingelheim, Eli Lilly and Company. Board Member; Eli Lilly and Company. Advisory Panel; Abbott. Research Support; Endogenex, Versanis, AstraZeneca. D.N. O'Neal: None.
