Duodenal ReCET for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1)

Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)

This study is designed to evaluate the efficacy, safety, and mechanisms of ReCET procedure in patients with T2DM and its effect on MASLD.

Study Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus); MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Syndrome (MetS)
• Intervention / Treatment: Procedure: ReCET treatment

Detailed Description

This is a prospective, single-arm feasibility study enrolling individuals with type 2 diabetes mellitus (T2DM) who have failed to achieve adequate glycemic control with oral glucose-lowering medications. Participants will undergo the ReCET procedure and liver biopsies both prior to and after the procedure to evaluate its effects on metabolically associated fatty liver disease (MAFLD). They will be followed for 12 months to assess the primary endpoint and for a total of 2 years. Participants are permitted to undergo a repeat ReCET procedure once if they initially respond but experience a recurrence of suboptimal diabetes management between 1 and 2 years after the procedure. They will be followed up for an additional year after the repeated procedure.

• 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 Contact Backup: Name: Jenny Study coordinator; Phone Number: +85235052956; Email: jennyho@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
    • Principal Investigator: Stephen Ng, FRCSEd(Gen)
    • Sub-Investigator: Alice Kong, MD
    • Sub-Investigator: Raymond Tang, MD
    • Sub-Investigator: Derek Xia, PhD(CUHK)
    • Sub-Investigator: Jimmy Lai, FRCP(Edin)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Duration of T2DM < 10 years
• BMI 18.5-40kg/m2
• Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs

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 1 DM, DM secondary to specific disease or having any history of ketoacidosis
• Patients on insulin
• 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
• Patients with cirrhosis due to causes other than MASLD
• 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	Change in HbA1c (%) from baseline to Month 24	24 months post-procedure
Improvement of MAFLD	Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Faecal microbiome	changes in faecal microbiome from baseline to Month 24	24 months post-procedure
Changes in background glucose lowering medications	Changes in glucose lowering medications 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): April 1, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2033

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Metabolic Syndrome
• Other Study ID Numbers: CRE-2025.876

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