Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

NCT05859022 | Recruiting

• 1 other identifier: BEOD trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bariatric surgery; embolization; intensive medical therapy; BMI; glycemia

Outcome Measures

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.

  12 months

Secondary Outcomes (10)

• Determination of glycemic level (mg/dL)

  up to 48 months

• Weight evaluation in Kg

  up to 48 months

• Blood pressure measurement

  up to 48 months

• Determination of lipid levels

  up to 48 months

• Determination of renal function

  up to 48 months

Study Arms (2)

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

EXPERIMENTAL

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

Bariatric Arterial Embolization (BAE)

EXPERIMENTAL

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.

Other: Bariatric Arterial Embolization (BAE) procedure

Interventions

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

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.

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

Bariatric Arterial Embolization (BAE) procedure OTHER

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

Bariatric Arterial Embolization (BAE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ) 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.

You may not qualify if:

• 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.
• Known history of chronic liver disease (except for NAFLD/NASH), hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency.
• Gastrointestinal disorders including a known history of celiac disease and/or other malabsorptive disorders or inflammatory bowel disease (Chron's disease or ulcerative colitis).
• Psychiatric disorders including dementia, active psychosis, severe depression requiring \>2 medications, history of suicide attempts, alcohol or drugs abuse with previous 12months.
• Pregnancy.
• Malignancy within 5 years (except squamous cell and basal cell cancer of skin).
• Anaemia defined as haemoglobin less than 9 in females and 10 in males.
• Any medical condition requiring anticoagulation therapy that cannot be temporarily discontinued for surgical or embolic approach.
• Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study.
• Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the informed consent form.
• Severe pulmonary disease.
• American Society of Anesthesiologists (ASA) physical status class IV or higher.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• cruz vermelha hospital: collaborator

Study Sites (1)

Cruz Vermelha Hospital

Lisbon, 1549-008, Portugal

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo O. Oliveira, MD

  cruz vermelha hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo O. Oliveira, MD

CONTACT

+351934426720; rtavio.oliveira@gmail.com

Silvia V. Conde, PhD

CONTACT

+351918974400; silvia.conde@nms.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients assigned for one of 2 arms: Roux-en-Y gastric By-pass (RYGB),bariatric arterial embolization (BAE).

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 15, 2023
• Study Start: June 16, 2021
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From 24months some data will be shared and till the end of the project at 48months after recruitment of all patients
• Access Criteria: Results from the present study will be presented in several national and international meetings and published in scientific journals. The PhD dissertation will be done by compiling the articles published in the context of this project.

Locations

PT (1)