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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Roux-en-Y gastric By-pass (RYGB) surgery
Other interventionRYGB procedure requires 1-2 hours of operating time and two to three days length of hospital stay. Use the Kit-RYGB by J\& company.
Bariatric Arterial Embolization (BAE) procedure
Other interventionuse of Embosphere Microspheres (EM) that are designed to offer controlled, target embolization.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Roux-en-Y gastric By-pass (RYGB)Experimental treatment 1 intervention
Group B: Bariatric Arterial Embolization (BAE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with glycated haemoglobin < 6%
The primary outcome of the study will be a level of glycated haemoglobin of 6.0% or less without the use of diabetes medications.
Time frame
12 monthsSecondary outcomes
1
Determination of glycemic level (mg/dL)
Measures of glycemic control by evaluating glycemic level at fast in the blood in mg/dL. less than 126mg/dL will represent a good glycemic control
Time frame
up to 48 months2
Weight evaluation in Kg
Evaluation of weight loss in Kg from the first appointment and during the different admissions time-points of each patient
Time frame
up to 48 months3
Blood pressure measurement
Evaluation of mean blood pressure in mmHg in the first appointment and during the entire trial
Time frame
up to 48 months4
Determination of lipid levels
Evaluation of lipid levels in the first appointment and during the entire trial
Time frame
up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade Nova de Lisboa
Lead sponsor
cruz vermelha hospital
Collaborator
Source ClinicalTrials.gov