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ENDOSCOPIC APPLICATION OF PULSED ELECTRIC FIELD IN DUODENUM FOR IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES—A PROSPECTIVE FEASIBILITY STUDY
Date
May 18, 2024
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Background
Type II diabetes (T2D) pathogenesis is linked with diabetes-associated duodenal alterations, presenting a potential regnerative therapeutic target. The Endoscopic Re-Cellularization via Electroporation Therapy (ReCET™) procedure, a pioneering non-thermal method, employs pulsed electric fields (PEF) to stimulate intestinal cell regeneration. This abstract presents updated findings from an ongoing feasibility study in the United States, evaluating ReCET as a treatment modality for T2D (NCT05014204).
Methods
This is a prospective, multicenter, feasibility study conducted in three US centers. Eligibility criteria include 22-65 years of age, on 2-3 non-insulin glucose-lowering medications, HbA1c 7.5%-10.0% and BMI 24-40 kg/m2. The procedure involves transesophageal placement of the ReCET catheter and endoluminal delivery of PEF to the duodenal wall (Figure 1). Patients are followed for 12 months with endoscopy at 4 weeks. The background medications are maintained for 12 weeks before and 24 weeks after the procedure. The primary endpoint is device/procedure-related serious adverse events (SAEs) at 12 weeks. Secondary endpoints include procedure success and glycemic parameters.
Results: Twenty participants have been enrolled (100%), with an average age of 55.7 ± 7.4 years, predominantly male (70%), and an average BMI of 32.4 ± 4.3 kg/m2. The average duration of T2D was 6.6 ± 2.1 years, and baseline HbA1c was 8.3 ± 0.5% (Table 1). The procedure was successfully completed in all cases, with an average treatment length of 12.3 ± 2.4 cm. All participants were discharged on the same day of the procedure. There were no device/procedure-related SAEs reported. The most common adverse event was a sore throat, occurring in 14 out of 20 participants, and resolved within few days. Complete mucosal healing was observed in the 4-week follow-up endoscopy, with no evidence of strictures or other abnormalities. Among participants who reached the 24-week, 73% achieved an HbA1c ≤7.0%. Improvements in HbA1c and time in range on continuous glucose monitoring were significant, with changes of -1.5 ± 0.4 % (p<0.001) and +28.6 ± 30.8 % (p< 0.05) at 12 weeks, respectively.
Conclusions: The application of PEF in the duodenum using the ReCET device has been demonstrated to be technically feasible and safe. The observed improvements in glycemic control are substantial and warrant further investigation.
Type II diabetes (T2D) pathogenesis is linked with diabetes-associated duodenal alterations, presenting a potential regnerative therapeutic target. The Endoscopic Re-Cellularization via Electroporation Therapy (ReCET™) procedure, a pioneering non-thermal method, employs pulsed electric fields (PEF) to stimulate intestinal cell regeneration. This abstract presents updated findings from an ongoing feasibility study in the United States, evaluating ReCET as a treatment modality for T2D (NCT05014204).
Methods
This is a prospective, multicenter, feasibility study conducted in three US centers. Eligibility criteria include 22-65 years of age, on 2-3 non-insulin glucose-lowering medications, HbA1c 7.5%-10.0% and BMI 24-40 kg/m2. The procedure involves transesophageal placement of the ReCET catheter and endoluminal delivery of PEF to the duodenal wall (Figure 1). Patients are followed for 12 months with endoscopy at 4 weeks. The background medications are maintained for 12 weeks before and 24 weeks after the procedure. The primary endpoint is device/procedure-related serious adverse events (SAEs) at 12 weeks. Secondary endpoints include procedure success and glycemic parameters.
Results: Twenty participants have been enrolled (100%), with an average age of 55.7 ± 7.4 years, predominantly male (70%), and an average BMI of 32.4 ± 4.3 kg/m2. The average duration of T2D was 6.6 ± 2.1 years, and baseline HbA1c was 8.3 ± 0.5% (Table 1). The procedure was successfully completed in all cases, with an average treatment length of 12.3 ± 2.4 cm. All participants were discharged on the same day of the procedure. There were no device/procedure-related SAEs reported. The most common adverse event was a sore throat, occurring in 14 out of 20 participants, and resolved within few days. Complete mucosal healing was observed in the 4-week follow-up endoscopy, with no evidence of strictures or other abnormalities. Among participants who reached the 24-week, 73% achieved an HbA1c ≤7.0%. Improvements in HbA1c and time in range on continuous glucose monitoring were significant, with changes of -1.5 ± 0.4 % (p<0.001) and +28.6 ± 30.8 % (p< 0.05) at 12 weeks, respectively.
Conclusions: The application of PEF in the duodenum using the ReCET device has been demonstrated to be technically feasible and safe. The observed improvements in glycemic control are substantial and warrant further investigation.
Figure 1. This figure illustrates the ReCET procedure, specifically highlighting the placement of the catheter within the duodenum. It also provides comparative views using narrow band imaging and magnification to demonstrate the duodenal mucosa both before and after the therapy. Notably, it emphasizes the mucosal changes attributable to the treatment, including complete healing and regeneration observed at the 4-week follow-up
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