Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Nova de Lisboa

About this trial

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

Qualifiers

Is the candidate for general anesthesia.

Body Mass Index (BMI) between 33 and 43 Kg/m2

Willing, able, and mentally competent to provide written informed consent.

Able o understand the options and to comply with the requirements of each program.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Roux-en-Y gastric By-pass (RYGB) surgery
  • Bariatric Arterial Embolization (BAE) procedure

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidade Nova de Lisboa

Lead sponsor

cruz vermelha hospital

Collaborator