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RECRUITING
NCT05859022
NA

Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

Sponsor: Universidade Nova de Lisboa

View on ClinicalTrials.gov

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.

Official title: Comparison of Metabolic Effects of Bariatric Arterial Embolization vs. Bariatric Surgery

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-06-16

Completion Date

2025-10

Last Updated

2024-12-11

Healthy Volunteers

Yes

Interventions

OTHER

Roux-en-Y gastric By-pass (RYGB) surgery

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.

OTHER

Bariatric Arterial Embolization (BAE) procedure

use of Embosphere Microspheres (EM) that are designed to offer controlled, target embolization.

Locations (1)

Cruz Vermelha Hospital

Lisbon, Portugal