Duodenal ReCET as an Early Treatment for Type 2 DM (DREAM-1)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Diabete Mellitus; T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
• Intervention / Treatment: Procedure: ReCET treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Ng, FRCSEd(Gen); Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Chinese University of Hong Kong
    • Contact: Stephen Ng, FRCSEd(Gen); Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk
    • Contact: Jenny Ho; Phone Number: +85235052956; Email: jennyho@surgery.cuhk.edu.hk
    • Sub-Investigator: Philip Chiu, FRCSEd(Gen), MD
    • Sub-Investigator: Alice Kong, FRCP(Edin), MD
    • Sub-Investigator: Derek Xia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Duration of T2DM </= 2 years
• HbA1c </= 7.5%
• On 0-1 oral diabetes medications

Exclusion Criteria:

• Previous treatment with ReCET or similar procedure
• Previous GI surgery that could preclude the ability to perform ReCET, or acute gastric and duodenal pathology that increased the risk of ReCET
• Type I DM, DM secondary to specific disease or having any history of ketoacidosis
• Fasting C-peptide level <0.5ug/L
• Any inflammatory disease of the gastrointestinal tract such as Crohn's disease
• Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy
• Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and/or there is a need or expected need to use during the study period
• Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
• Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month
• Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.
• Patients with contra-indications to endoscopy
• Malignancy
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
• Pregnant or breast feeding
• ASA grade IV & V
• Mental or psychiatric disorder; Drug or alcohol addiction
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endoscopic duodenal recellularization via electroporation therapy (ReCET); ReCET procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c ≤6.5% without glucose lowering drugs	Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c (%) from baseline to Month 24	24 months post-procedure
Total body weight loss (%TBWL)	Percent total body weight loss (%TBWL) from baseline to Month 24	24 months post-procedure
Incidence of adverse events	Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)	within 30 days post-procedure
Body fat percentage	Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24	24 months post-procedure
Change in Quality of Life	measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24	24 months post-procedure
Hepatic steatosis index	level from baseline to Month 24	24 months post-procedure

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Stephen Ng, FRCSEd(Gen), Prince of Wales Hospital, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): February 28, 2032

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Fatty Liver; Nutritional and Metabolic Diseases; Diabetes Mellitus; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CRE-2025.801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No