NCT05859022

Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The present project is a prospective, randomized, no-blinded, controlled and interventional clinical single- center study, which seeks to compare the impact of the following interventions: Roux-en-Y gastric By-pass (RYGB) and bariatric arterial embolization (BAE) on metabolic control in patients with DMT2 and BMI between 30-43 Kg/m2 over 2 years. Study initial recruitment will be achieved by an awareness campaign, which will emphasize a study of methods of diabetes management and include identification of patients into treatment at Cruz Vermelha Hospital. The investigator will initially pre-screen patients for the inclusion and exclusion criteria. Detailed information regarding of Diabetes, Obesity and randomization arms of the study would be provided in service meeting. Evaluation of the inclusion and exclusion criteria will occur both at the initial screening visit and the baseline visit prior to randomization. Patients who fail to be include during initial screening may be considered for re-consenting when clinically appropriate, and will have screening/baseline procedures repeated at the discretion of the Investigator. Patients who fail to be include during initial screening based on glycated hemoglobin (HbA1c) and or BMI and are re/screened within 6 months, will only have the baseline HbA1c and BMI repeated. On visit 2 (after 30 days) the 60 patients randomized per study arm for embolization or surgery procedures will be evaluated by the anaesthetist. RYGB or BAE will be scheduled as soon as possible after randomization. After BAE or surgery, patients will be followed 1, 3, 6 and 12 months. At 12 months visit patients will be evaluated for primary endpoint of percent of treatment group achieving HbA1c ≤ 6%. Pre-specified secondary outcomes include measures of glycaemic control, weight loss, mean blood pressure, lipid levels, renal function, assessment of diabetes quality of life (DQoL) and biomarkers in blood. Also, metabolic parameters and other markers will be evaluated from liver and adipose tissue biopsies collected at the beginning of the RYGB surgery to correlate with biochemical evaluations. During the follow-up visits primary and secondary outcomes will be evaluated by different techniques and approaches: body weight loss will be evaluated by bioimpedance analysis; blood will be collected for HbAlc, fasting glucose, lipids, comprehensive Metabolic Panel, Urinalysis (microalbumin and creatinine) and hepatogram by common clinical analysis; the diabetes quality of life (DQoL) question; liver and adipose tissues will be collected during the surgical procedure to asses by western blot the levels of each adenosine receptors, adipokynes, cytokines and inflammatory markers receptors.

Conditions

• Obesity
• Type2diabetes
• Bariatric Surgery Candidate
• Metabolic Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-16
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2023-05-15
• Last updated: 2024-12-11

Locations

1 site across 1 country: Portugal