Overview
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).
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.
Eligibility
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
