Comparing the effects of bariatric arterial embolization and gastric bypass on obesity and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the metabolic effects of bariatric arterial embolization (BAE) compared to Roux-en-Y gastric bypass (RYGB) in patients with obesity and Type 2 diabetes mellitus (DMT2). It is a prospective, randomized, controlled study conducted at Cruz Vermelha Hospital, where 60 patients will be assigned to either intervention over a two-year period. The study will assess the resolution of DMT2 and metabolic control in participants with a BMI between 30-43 Kg/m2. Initial recruitment will involve an awareness campaign to identify eligible patients, followed by screening and randomization.

Why it matters

Who can join: the full rules

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

Where it's running

• Cruz Vermelha Hospital
  Lisbon, Portugal Recruiting

Study contacts

• Principal investigator: Rodrigo O. Oliveira, MD — cruz vermelha hospital
• Study coordinator: Rodrigo O. Oliveira, MD
• Email: rtavio.oliveira@gmail.com
• Phone: +351934426720

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.