Actively Recruiting
Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery
Led by Universidade Nova de Lisboa · Updated on 2024-12-11
30
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
Sponsors
U
Universidade Nova de Lisboa
Lead Sponsor
C
cruz vermelha hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for general anesthesia
- Body Mass Index (BMI) between 33 and 43 Kg/m2
- Biochemical evidence of Type 2 Diabetes Mellitus confirmed by American Diabetes Association criteria: treated with HbA1c 7.1% or untreated with fasting 2-hour plasma glucose level of 200 mg/dL and HbA1c of 7.1%
- Willing, able, and mentally competent to provide written informed consent
- Able to understand the options and comply with study requirements
- Negative urine pregnancy test at screening and baseline visits for women of childbearing potential
- Female patients must agree to use reliable contraception for 2 years
You will not qualify if you...
- Prior bariatric surgery of any kind
- Prior complex abdominal surgery including splenectomy, upper GI, anti-reflux surgery, and trauma
- Abdominal, thoracic, pelvic, or obstetric-gynaecologic surgery within 3 months or at surgeon's discretion
- Cardiovascular conditions including uncompensated congestive heart failure, dysrhythmia, history of stroke, or uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
- Known chronic liver disease (except NAFLD/NASH), hepatitis, positive tests for hepatitis B or C, or alpha-1-antitrypsin deficiency
- Gastrointestinal disorders including celiac disease, malabsorptive disorders, or inflammatory bowel disease
- Psychiatric disorders such as dementia, active psychosis, severe depression requiring more than 2 medications, history of suicide attempts, recent alcohol or drug abuse
- Pregnancy
- Malignancy within 5 years except certain skin cancers
- Anemia defined as hemoglobin less than 9 in females and 10 in males
- Medical conditions requiring anticoagulation therapy that cannot be temporarily stopped
- Any major illness placing the subject at undue risk
- Use of investigational therapy or participation in another trial within 12 weeks prior to consent
- Severe pulmonary disease
- American Society of Anesthesiologists physical status class IV or higher
- History of allergy to iodinated contrast media
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Trial Site Locations
Total: 1 location
1
Cruz Vermelha Hospital
Lisbon, Portugal, 1549-008
Actively Recruiting
Research Team
R
Rodrigo O. Oliveira, MD
CONTACT
S
Silvia V. Conde, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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