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Duodenal pulsENDO as an Early Treatment for Type 2 DM

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About this study

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).

Condition
Diabete Mellitus, T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Tested
pulsENDO treatment
Sponsor
Chinese University of Hong Kong

Who can join

Age
18 to 60 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Maximum age: 60 years
  • Study condition: Diabete Mellitus, T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
  • Duration of T2DM \</= 2 years
  • HbA1c \</= 7.5%
  • On 0-1 oral diabetes medications

Exclusion 19

  • 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

Where

1 site, 1 recruiting

Chinese University of Hong Kong

Shatin, Hong Kong

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.