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Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

NCT05859022 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Obesity
  • Type2diabetes
  • Bariatric Surgery Candidate
  • Metabolic Disease

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.

Sponsors & Collaborators

  • cruz vermelha hospital

    collaborator UNKNOWN

  • Universidade Nova de Lisboa

    lead OTHER

Principal Investigators

  • Rodrigo O. Oliveira, MD · cruz vermelha hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859022 on ClinicalTrials.gov