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NCT07376486Recruiting

Duodenal pulsENDO as an Early Treatment for Type 2 DM

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

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
22 Jan 2026
Start date
1 Sept 2026
Primary completion date
28 Feb 2031
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT07376486

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Sept 2026 to the primary completion date, 28 Feb 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Type I DM, DM secondary to specific disease or having any history of ketoacidosis
  • 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
  • Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.
  • Malignancy
  • Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
  • Mental or psychiatric disorder; Drug or alcohol addiction

Lab values

  • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy

Other

  • Fasting C-peptide level \<0.5ug/L
  • Patients with contra-indications to endoscopy
  • Pregnant or breast feeding
  • ASA grade IV \& V
  • Other cases deemed by the examining physician as unsuitable for safe treatment
  • Refusal to participate

Who the study is looking for

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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese University of Hong Kong
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.