Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery
Trial Parameters
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