NCT05859022 Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

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This trial targets 30 participants in total. It began in 2021-06-16 with a primary completion date of 2025-08.

Brief Summary

Obesity and Type 2 diabetes mellitus (DMT2) are two of the most common chronic diseases of the Western society. Obesity is one critical factor in DMT2 development, with weight loss having profound beneficial effects on DMT2 and improving the metabolic pathophysiology leading to hyperglycemia. Observational studies reported that surgical intervention of morbid obesity achieved significant improvement of resolution of DMT2, both in short and long-term. Bariatric surgery has been considered the best option for treatment of diabetic obese patients, with the laparoscopic Roux-en-Y Gastric Bypass being the gold standard of the surgical treatment. Bariatric arterial embolization (BAE) technique has proved to be safe effective for weight loss in obese patients, but its metabolic effects have not been studied yet. The hypothesis of the study is that BAE is effective for the resolution of DMT2 inpatients with BMI between 30-43 Kg/m2. The aim is to assess DMT2 remission after BAE and bariatric surgery, to analyze potential conditioning factors, and to compare remission criteria between bariatric surgery and BAE.

Eligibility Criteria

Inclusion Criteria: * criteria: 1. Is the candidate for general anesthesia. 2. Body Mass Index (BMI) between 33 and 43 Kg/m2 3. 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%. 4. Willing, able, and mentally competent to provide written informed consent. 5. Able o understand the options and to comply with the requirements of each program. 6. Have a negative urine pregnancy test at screening and baseline visits (prior surgery and Embolization) for women of childbearing potential. 7. Female patients must agree to use reliable method of contraception for 2 years. Exclusion Criteria: 1. Prior bariatric surgery of any kind. 2. Prior complex abdominal surgery including splenectomy, upper GI, anti-reflux surgery and trauma. 3. Abdominal, thoracic, pelvic and/or obstetric-gynaecologic surgery within 3 months or at the discretion of the surgery. 4. 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. 5. 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. 6. Gastrointestinal disorders including a known history of celiac disease and/or other malabsorptive disorders or inflammatory bowel disease (Chron's disease or ulcerative colitis). 7. Psychiatric disorders including dementia, active psychosis, severe depression requiring \>2 medications, history of suicide attempts, alcohol or drugs abuse with previous 12months. 8. Pregnancy. 9. Malignancy within 5 years (except squamous cell and basal cell cancer of skin). 10. Anaemia defined as haemoglobin less than 9 in females and 10 in males. 11. Any medical condition requiring anticoagulation therapy that cannot be temporarily discontinued for surgical or embolic approach. 12. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study. 13. Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the informed consent form. 14. Severe pulmonary disease. 15. American Society of Anesthesiologists (ASA) physical status class IV or higher. 16. History of allergy to iodinated contrast media

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