Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

Launched by UNIVERSIDADE NOVA DE LISBOA · May 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for helping people with obesity and Type 2 diabetes: bariatric arterial embolization (BAE) and bariatric surgery. The researchers want to see how each method affects weight loss and the resolution of diabetes in patients. Bariatric surgery, especially a type called laparoscopic Roux-en-Y gastric bypass, is already known to help many people with these conditions. However, BAE is a newer procedure that hasn’t been studied as much, and the trial aims to find out if it can also help improve diabetes and metabolic health.

To participate in this study, candidates need to be between 18 and 75 years old, have a body mass index (BMI) between 33 and 43, and have been diagnosed with Type 2 diabetes. They also need to be able to undergo general anesthesia and give informed consent. Participants will be closely monitored throughout the trial to see how well each procedure works for controlling diabetes and aiding in weight loss. It’s important to know that certain medical conditions and prior surgeries may prevent someone from joining the trial, so potential participants should discuss their health history with their doctor to see if they qualify.

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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