Duodenal ReCET as an Early Treatment for Type 2 DM (DREAM-1)

The Chinese University of Hong Kong

Status: Begins enrollment this month

Conditions: Diabete Mellitus; T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

Treatments: Procedure: ReCET treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07376486

CRE-2025.801

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous treatment with ReCET or similar procedure
• Previous GI surgery that could preclude the ability to perform ReCET, or acute gastric and duodenal pathology that increased the risk of ReCET
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Endoscopic duodenal recellularization via electroporation therapy (ReCET)

Experimental group

Description:

ReCET procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE)

Treatment:

Procedure: ReCET treatment