T2DM (Type 2 Diabetes Mellitus)DRESS-1NCT07390422
Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease
A study testing pulsENDO treatment in people with T2DM (Type 2 Diabetes Mellitus) and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome (MetS)
- What is being tested?
- pulsENDO treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2026to 30 Aug 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous treatment with pulsENDO or similar procedure
- Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Shatin
Stephen Ng, FRCSEd(Gen), +85235052956, stephenng@surgery.cuhk.edu.hk
Jenny Ho, +85235052956, jennyho@surgery.cuhk.edu.hk
About this study
Official title: 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 pulsENDO procedure in patients with T2DM and its effect on MASLD.
Read the 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 pulsENDO 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 pulsENDO 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.
- Conditions
- T2DM (Type 2 Diabetes Mellitus), MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome (MetS)
- Being tested
- pulsENDO treatment
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsENDO treatmentProcedure or surgery
The pulsENDO procedure utilizes the pulsENDO 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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic duodenal recellularization via electroporation therapy (pulsENDO) | Experimental | pulsENDO procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE) Receives: Procedure: pulsENDO treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c (%) from baseline to Month 24
Measured: 24 months post-procedure
Improvement of MAFLD
Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology
Measured: 12 months post-procedure
Secondary outcomes (6)
Total body weight loss (%TBWL)
Percent total body weight loss (%TBWL) from baseline to Month 24
Measured: 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)
Measured: within 30 days post-procedure
Body fat percentage
Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24
Measured: 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
Measured: 24 months post-procedure
Faecal microbiome
changes in faecal microbiome from baseline to Month 24
Measured: 24 months post-procedure
Changes in background glucose lowering medications
Changes in glucose lowering medications from baseline to Month 24
Measured: 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2031 (estimated)
- Study completion30 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen KK Ng, Chinese University of Hong Kong
- Investigators
- Stephen Ng, FRCSEd(Gen), Principal investigator, Prince of Wales Hospital, the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390422
- Sponsor's protocol ID
- CRE-2025.876
- Acronym
- DRESS-1
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided