Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

Ki vehet részt

• criteria:; Is the candidate for general anesthesia; Body Mass Index (BMI) between 33 and 43 Kg/m2; Patients have a biochemical evidence of Type 2 Diabetes Mellitus (DMT2) confirmed by American Diabetes Association (ADA) criteria:; 3.1) treated - HbA1c 7,1%; 3.2) If untreated- fasting 2-hour plasma glucose level of 200 mg/dL during an oral glucose tolerance test and a HbA1c of 7,1%; Willing, able, and mentally competent to provide written informed consent; Able o understand the options and to comply with the requirements of each program; Have a negative urine pregnancy test at screening and baseline visits (prior surgery and Embolization) for women of childbearing potential; Female patients must agree to use reliable method of contraception for 2 years

Ki nem vehet részt

• Prior bariatric surgery of any kind
• Prior complex abdominal surgery including splenectomy, upper GI, anti-reflux surgery and trauma
• Abdominal, thoracic, pelvic and/or obstetric-gynaecologic surgery within 3 months or at the discretion of the surgery
• Cardiovascular conditions including uncompensated congestive heart failure, dysrhythmia, history of stroke, or uncontrolled hypertension (defined as medically treated with the mean of 3 separate measurements systolic blood pressure (SBP)> 180 mmHg or diastolic blood pressure (DBP) >110mmHg). Patients with coronary artery disease (CAD) that have been successfully treated with coronary artery by-pass graft (CABG) or percutaneous coronary intervention (PCI) or are 1 year after implantation of drug eluting stent and have no evidence of active ischemia are eligible
• Psychiatric disorders including dementia, active psychosis, severe depression requiring >2 medications, history of suicide attempts, alcohol or drugs abuse with previous 12months
• Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the informed consent form
• Known history of chronic liver disease (except for NAFLD/NASH), hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency
• Gastrointestinal disorders including a known history of celiac disease and/or other malabsorptive disorders or inflammatory bowel disease (Chron's disease or ulcerative colitis)
• Malignancy within 5 years (except squamous cell and basal cell cancer of skin)
• Any medical condition requiring anticoagulation therapy that cannot be temporarily discontinued for surgical or embolic approach
• Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
• Severe pulmonary disease
• History of allergy to iodinated contrast media
• Anaemia defined as haemoglobin less than 9 in females and 10 in males
• Pregnancy
• American Society of Anesthesiologists (ASA) physical status class IV or higher