ObesityBEODNCT05859022
Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery
A study testing Roux-en-Y gastric By-pass (RYGB) surgery and Bariatric Arterial Embolization (BAE) procedure in people with Obesity and Type2diabetes, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type2diabetes, Bariatric Surgery Candidate
- What is being tested?
- Roux-en-Y gastric By-pass (RYGB) surgery and Bariatric Arterial Embolization (BAE) procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 16 Jun 2021to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 3.1) 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.
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- 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.
Who cannot join
- 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).
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- 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.
- History of allergy to iodinated contrast media
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Cruz Vermelha Hospital
Lisbon, 1549-008
Otavio O. Oliveira, MD, +351934426720, rtavio.oliveira@gmail.com
Silvia V. Conde, PhD, +351918974400, silvia.conde@nms.unl.pt
About this study
Official title: Comparison of Metabolic Effects of Bariatric Arterial Embolization vs. Bariatric Surgery
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.
Read the 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
- Being tested
- Roux-en-Y gastric By-pass (RYGB) surgery, Bariatric Arterial Embolization (BAE) procedure
- Keywords
- bariatric surgery, embolization, intensive medical therapy, BMI, glycemia
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric By-pass (RYGB) surgeryOther
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.
Bariatric Arterial Embolization (BAE) procedureOther
use of Embosphere Microspheres (EM) that are designed to offer controlled, target embolization.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Bariatric Arterial Embolization (BAE) procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
Determination of glycemic level (mg/dL)
Measures of glycemic control by evaluating glycemic level at fast in the blood in mg/dL. less than 126mg/dL will represent a good glycemic control
Measured: up to 48 months
Weight evaluation in Kg
Evaluation of weight loss in Kg from the first appointment and during the different admissions time-points of each patient
Measured: up to 48 months
Blood pressure measurement
Evaluation of mean blood pressure in mmHg in the first appointment and during the entire trial
Measured: up to 48 months
Determination of lipid levels
Evaluation of lipid levels in the first appointment and during the entire trial
Measured: up to 48 months
Determination of renal function
Evaluation of renal function by measuring creatinine levels in the blood in the first appointment and during the entire trial
Measured: up to 48 months
Assess diabetes quality of life (DQoL) questionnaire
Evaluation of diabetes quality of life (DQoL) questionnaire in the first appointment and during the entire trial. it will measure reliability and validity of a diabetes quality-of-life and will measure the diabetes control and complications. The instrument provides an overall scale score ranging from 0 (lowest DQoL score) to 100 (highest DQoL score), as well as four subscale scores for: 1- satisfaction with treatment, 2- impact of treatment, 3- worry about the future effects of diabetes, and 4- worry about social/vocational issues.
Measured: up to 48 months
Evaluation of adenosine metabolism in liver and adipose tissue biopsies
evaluation of adenosine receptors protein levels (A1R, A2aR, A2bR) (given in % of protein levels from control) on liver and adipose tissue collected at the beginning of RYGB surgery. the evaluation of the 3 receptors levels will allow to evaluate adenosine metabolism in a whole.
Measured: At the beginning of the RYGB surgery
Evaluation of adipokines in adipose tissue biopsies
Evaluation of adipokines protein levels (leptin, adiponectin and resistin; given in % of protein levels from control) on adipose tissue collected at the beginning of RYGB surgery. the evaluation of the adipokines levels will allow to evaluate overall adipose tissue function.
Measured: At the beginning of the RYGB surgery
Evaluation of cytokines in liver and adipose tissue biopsies
evaluation of cytokines protein levels [interleukin 10 (IL10), tumor necrosis factor alpha (TNFalpha), interleukin 6 (IL6); given in % protein levels from the control) on liver and adipose tissue collected at the beginning of RYGB surgery. the evaluation of cytokines on both tissues will allow to determine the overall inflammatory status of the tissues.
Measured: At the beginning of the RYGB surgery
Evaluation of inflammatory receptors levels in liver and adipose tissue biopsies
evaluation of inflammatory receptors protein levels (IL10 receptor, TNFalpha receptor, IL6 receptor; given in % protein levels from the control) on liver and adipose tissue collected at the beginning of RYGB surgery. the evaluation of cytokines on both tissues will allow to determine the overall inflammatory status of the tissues.
Measured: At the beginning of the RYGB surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start16 Jun 2021
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients assigned for one of 2 arms: Roux-en-Y gastric By-pass (RYGB),bariatric arterial embolization (BAE).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- cruz vermelha hospital
- Responsible party
- Sponsor
- Investigators
- Rodrigo O. Oliveira, MD, Principal investigator, cruz vermelha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859022
- Sponsor's protocol ID
- BEOD trial
- Acronym
- BEOD
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in publications and a Philosophy doctor (PhD) thesis
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Metabolic Effects of Bariatric Arterial Embolization vs. Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05859022
- Acronym / sponsor ID
- BEOD / BEOD trial
- Conditions
- Obesity, Type2diabetes, Bariatric Surgery Candidate, Metabolic Disease
- Keywords
- bariatric surgery, embolization, intensive medical therapy, BMI, glycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- cruz vermelha hospital
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients assigned for one of 2 arms: Roux-en-Y gastric By-pass (RYGB),bariatric arterial embolization (BAE).
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric By-pass (RYGB) | Experimental | Other: Roux-en-Y gastric By-pass (RYGB) surgeryRYGB procedure requires 1-2 hours of operating time and two to three days length of hospital stay. Use the Kit-RYGB by J\& company. |
| Bariatric Arterial Embolization (BAE) | Experimental | Other: Bariatric Arterial Embolization (BAE) procedureEmbosphere 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- criteria:
- 3.1) 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%.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric By-pass (RYGB) surgeryRYGB 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) |
| Bariatric Arterial Embolization (BAE) procedureuse of Embosphere Microspheres (EM) that are designed to offer controlled, target embolization. | Other | Bariatric Arterial Embolization (BAE) |
Primary outcome
Number of participants with glycated haemoglobin < 6%
Time frame: 12 months
The primary outcome of the study will be a level of glycated haemoglobin of 6.0% or less without the use of diabetes medications.
10 secondary outcomes
Determination of glycemic level (mg/dL)
Time frame: up to 48 months
Weight evaluation in Kg
Time frame: up to 48 months
Blood pressure measurement
Time frame: up to 48 months
Determination of lipid levels
Time frame: up to 48 months
Determination of renal function
Time frame: up to 48 months
Assess diabetes quality of life (DQoL) questionnaire
Time frame: up to 48 months
Evaluation of adenosine metabolism in liver and adipose tissue biopsies
Time frame: At the beginning of the RYGB surgery
Evaluation of adipokines in adipose tissue biopsies
Time frame: At the beginning of the RYGB surgery
Evaluation of cytokines in liver and adipose tissue biopsies
Time frame: At the beginning of the RYGB surgery
Evaluation of inflammatory receptors levels in liver and adipose tissue biopsies
Time frame: At the beginning of the RYGB surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in publications and a Philosophy doctor (PhD) thesis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo O. Oliveira, MD principal investigator
cruz vermelha hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric By-pass (RYGB) surgery and Bariatric Arterial Embolization (BAE) procedure in people with Obesity and Type2diabetes, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo O. Oliveira, MD (+351934426720, rtavio.oliveira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with glycated haemoglobin < 6% (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.