Comparison of Metabolic Effects of Bariatric Arterial Embolization vs. Bariatric Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• criteria:

‣ Is the candidate for general anesthesia.

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

⁃ Patients have a biochemical evidence of Type 2 Diabetes Mellitus (DMT2) confirmed by American Diabetes Association (ADA) criteria:

∙ 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%.

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

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

⁃ Have a negative urine pregnancy test at screening and baseline visits (prior surgery and Embolization) for women of childbearing potential.

⁃ Female patients must agree to use reliable method of contraception for 2 years.

Locations
Other Locations
Portugal
Cruz Vermelha Hospital
RECRUITING
Lisbon
Contact Information
Primary
Rodrigo O. Oliveira, MD
rtavio.oliveira@gmail.com
+351934426720
Backup
Silvia V. Conde, PhD
silvia.conde@nms.unl.pt
+351918974400
Time Frame
Start Date: 2021-06-16
Estimated Completion Date: 2025-10
Participants
Target number of participants: 30
Treatments
Experimental: Roux-en-Y gastric By-pass (RYGB)
RYGB procedure requires 1-2 hours of operating time and two to three days length of hospital stay. Use the Kit-RYGB by J\& company.
Experimental: Bariatric Arterial Embolization (BAE)
Embosphere Microspheres (EM) are designed to offer controlled, target embolization. BAE procedure requires 1hour of operating time and one day length of hospital stay. Use the Kit by Merit MedicalCompany.
Sponsors
Collaborators: cruz vermelha hospital
Leads: Universidade Nova de Lisboa

This content was sourced from clinicaltrials.gov