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NCT Number: NCT07376486

Duodenal pulsENDO as an Early Treatment for Type 2 DM

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).

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Shatin, Hong Kong

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

pulsENDO treatment

Procedure

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.

Primary outcomes

  1. HbA1c ≤6.5% without glucose lowering drugs

    Time frame: 6 months post-procedure

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

Secondary outcomes

  1. HbA1c

    Time frame: 24 months post-procedure

    Change in HbA1c (%) from baseline to Month 24

  2. Total body weight loss (%TBWL)

    Time frame: 24 months post-procedure

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

  3. Incidence of adverse events

    Time frame: within 30 days post-procedure

    Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

  4. Body fat percentage

    Time frame: 24 months post-procedure

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

  5. Change in Quality of Life

    Time frame: 24 months post-procedure

    measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24

  6. Hepatic steatosis index

    Time frame: 24 months post-procedure

    level from baseline to Month 24

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: DREAM-1

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jan 29, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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