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Not yet recruiting NCT07390422

Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease

No phase Interventional T2DM (Type 2 Diabetes Mellitus) MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Syndrome (MetS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pulsENDO treatment.
Who it may be relevant to
Registry conditions: T2DM (Type 2 Diabetes Mellitus), MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Syndrome (MetS). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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 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.

Interventions

  • Procedure pulsENDO treatment
    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 outcome measures

  • HbA1c [Time frame: 24 months post-procedure]
  • Improvement of MAFLD [Time frame: 12 months post-procedure]
Secondary outcome measures (6)
  • Total body weight loss (%TBWL) [Time frame: 24 months post-procedure]
  • Incidence of adverse events [Time frame: within 30 days post-procedure]
  • Body fat percentage [Time frame: 24 months post-procedure]
  • Change in Quality of Life [Time frame: 24 months post-procedure]
  • Faecal microbiome [Time frame: 24 months post-procedure]
  • Changes in background glucose lowering medications [Time frame: 24 months post-procedure]

Eligibility criteria

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 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT07390422 · CRE-2025.876

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗