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Diabete MellitusDREAM-1NCT07376486

Duodenal pulsENDO as an Early Treatment for Type 2 DM

A study testing pulsENDO treatment in people with Diabete Mellitus and T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin), run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
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 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

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 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stephen Ng, FRCSEd(Gen) contact

+85235052956

stephenng@surgery.cuhk.edu.hk

Hong Kong1 site, 1 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

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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 using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

Read the 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.

Being tested
pulsENDO treatment
Medical subject headings
Diabetes Mellitus, Non-alcoholic Fatty Liver Disease

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 groups in NCT07376486
Study groupRoleWhat they receive
Endoscopic duodenal recellularization via electroporation therapy (pulsENDO)ExperimentalpulsENDO 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.

  1. HbA1c ≤6.5% without glucose lowering drugs

    Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs

    Measured: 6 months post-procedure

Secondary outcomes (6)

  1. HbA1c

    Change in HbA1c (%) from baseline to Month 24

    Measured: 24 months post-procedure

  2. Total body weight loss (%TBWL)

    Percent total body weight loss (%TBWL) from baseline to Month 24

    Measured: 24 months post-procedure

  3. 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

  4. Body fat percentage

    Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24

    Measured: 24 months post-procedure

  5. 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

  6. Hepatic steatosis index

    level 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.

  1. First posted29 Jan 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion28 Feb 2031 (estimated)
  4. Study completion30 Aug 2032 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07376486
Sponsor's protocol ID
CRE-2025.801
Acronym
DREAM-1
Status last verified
Sep 2026
First submitted
22 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

Questions about this trial

What is this clinical trial studying?

A study testing pulsENDO treatment in people with Diabete Mellitus and T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin), run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephen Ng, FRCSEd(Gen) (+85235052956, stephenng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c ≤6.5% without glucose lowering drugs (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07376486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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