Overview
This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
Description
This is a prospective, single-armed, feasibility study enrolling individuals with obesity and type 2 diabetes. Participants will be followed for a total of 2 years.
Eligibility
Inclusion Criteria:
- BMI \>/= 27kg/m2
- Known T2DM
- Individualized Metabolic Surgery (IMS) score 25-115
- HbA1c \<11% (subjects on oral glucose lowering drug(s) or HbA1c \<8% (subjects on insulin)
Exclusion Criteria:
- Previous treatment with ReCET, ESG or similar procedure
- Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG
- Type 1 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 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
