Conference Proceedings
First-in-Human Duodenal Endoscopic Recellularization via Electroporation Therapy for Type 2 Diabetes-An Interim Report
Cheng Yi Yuan, Adrian Sartoretto, Bronte Holt, Georgina Cameron, George Marinos, Fiona E Napier-Flood, Barham K Abu Dayyeh, David N O'Neal
DIABETES | AMER DIABETES ASSOC | Published : 2023
DOI: 10.2337/db23-835-P
Abstract
Background: We evaluated the feasibility and safety of endoscopic re-cellularization via electroporation therapy (ReCET) (Endogenex. Plymouth, MN) in restoring impaired duodenal signaling adversely impacting glucose control in type 2 diabetes (T2D). Method: We enrolled 30 adults with T2D: duration ≤10 years; HbA1c 7.5-11.0%; BMI of 24-40 kg/m2; C-peptide ≥333pmol/L; 1-4 non-insulin glucose-lowering medications (GLMs) at stable dose. Post-procedure GLMs were unchanged. Primary endpoint: Device or procedure-related serious adverse events (SAEs). Secondary endpoints: Changes in metabolic parameters at 24W. Results: The first 12 participants received single energy (..
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