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

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 1 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

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

• 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