Lead Sponsor

Radboud University Medical Center

Collaborators

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•Age between 18-65 years;
•Diagnosed with DM2
•* since at least 1 year
•* but diagnosed no longer than 10 years ago
•* currently under stable dose of insulin for at least 6 months
•HbA1c level of 7.0-11.0% (53-75 mmol/mol) prior to inclusion
•BMI of 30-40 kg/m² with or without hypertension
•Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to treatment, dietary follow up, visits as scheduled and all study specific procedures)
•Must be able to understand and be willing to provide written informed consent
•Must be eligible for general anesthesia or deep sedation with propofol

•Achalasia and any other esophageal motility disorders
•Severe esophagitis (grade C or D)
•Gastro-duodenal ulcer
•GI stenosis or obstruction
•Any history of esophageal or gastric surgery
•Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity
•Uncontrolled hypertension (systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>100 mm Hg under medication) during last 3 months;
•Severe renal, hepatic, pulmonary disease or cancer (cancer in the past 5 years, except basal cell carcinoma)
•Pregnancy, breast feeding or desire for pregnancy in the coming 12 months
•Any previous bariatric surgery, or endoscopic obesity-related intervention (including POSE, OverStitch, etc.). Intragastric balloon removed within the last 6 months
•Planned gastric surgery 60 days post intervention
•Anticoagulant therapy that cannot be temporarily stopped at the time of the procedure.
•Currently participating in other study (involving change of treatment) that did not reach its primary endpoint

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