NCT07376486

Duodenal ReCET as an Early Treatment for Type 2 DM

Duodenal Recellularization Via Electroporation Therapy as an Early Treatment for Type 2 Diabetes Mellitus (DREAM-1 Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

Detailed description

This is a prospective, single-armed, feasibility study enrolling individuals with a recent diagnosis of type 2 diabetes. Participants will be followed for 6 months for the primary endpoint and 2 years in total.

Conditions

• Diabete Mellitus
• T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

Interventions

Type	Name	Description
PROCEDURE	ReCET treatment	The ReCET procedure utilizes the ReCET catheter to deliver non-thermal pulsed electric field to the duodenum to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated.

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-08-30
• Completion: 2032-02-28
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: Hong Kong