bariatric embolization of arteries with imaging visible embolics (beatles)

Conditions: Obesity; Morbid Obesity; Weight Loss

Summary: the beatles study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. the goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.

the beatles study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. the goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥21 and ≤70 years * willing, able, and mentally competent to provide written informed consent * obese patients with a bmi ≥35 kg/m2 * weight ≤400 lb * vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3d ct angiography * suitable for protocol therapy, as determined by the interventional radiology investigator * adequate hematologic (neutrophils\>1.5x109/l, platelets\>70x109/l, international normalized ratio (inr\ 60milliliter ml/min. 1.73m2) function * for females of reproductive potential: agreement to use of highly effective contraception * for duration of study participation * patients who have failed conservative weight loss therapies such as supervised low calorie diets combined with behavior therapy and exercise * live or work within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs exclusion criteria: * hemoglobin a1c greater than 8% * patients who are currently taking either insulin or sulfonylurea (medication changes are allowed) * prior history of gastric, pancreatic, hepatic, and/or splenic surgery * prior radiation therapy to the upper abdomen * prior embolization to the stomach, spleen, or liver * cirrhosis * known portal venous hypertension * active peptic ulcer disease * significant risk factors for peptic ulcer disease, including daily nsaid use * large hiatal hernia, defined as \>5 cm in size * active h. pylori infection * known aortic pathology, such as aneurysm or dissection * renal insufficiency, as evidenced by an estimated glomerular filtration rate of \<60 milliliter(ml)/min * major comorbidity, such as active cancer, significant cardiovascular disease, or peripheral arterial disease * pregnancy * pre-existing chronic abdominal pain * positive stool occult blood study * gi bleeding or bleeding diathesis within 5 years * weight loss (intentional or unintentional) of more than or equal to 5% of body weight in the 6 months prior to randomization * a weight loss greater than 6lb during the weight management run- in * use of anti-obesity medications in the 12 months prior to screening * endoscopic findings that would preclude bariatric embolization (at the discretion of the study team) * history of gastric motility disorders or an abnormal nuclear gastric motility examination (to be performed in diabetic subjects only) * american society of anesthesiologists class 4 or 5 (very high risk surgical candidates: class 4=incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study - this exclusion criterion exists, because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects * inflammatory bowel disease * autoimmune disease or hiv+ * history of allergy to iodinated contrast media * failure to comply with pre-procedure weight management "run-in", or other pre-procedural visits (specifically, participants must complete 80% of weight management and lose it! food tracking, and 100% of one-time visits, i.e. mri, computed tomography angiography (cta), endoscopy) * applicability of any contraindication regarding patient's vasculature as per instruction for use * inability to have an mri scan (i.e., metal implants or claustrophobia) * smokers/vape users/tobacco use * active or new-onset endocrine disorders (stable disease acceptable) * other unforeseen conditions that may make patients unsuitable for the procedure (study team discretion) exclusion criteria (psychiatric): * as determined by clinical judgment based on clinical interview, psychological/behavioral measures, medical records, previous mental health records/other collateral information (as available) and consistent with diagnostic and statistical manual of mental disorders (dsm) -5 criteria: * diagnosis of severe mental illness (i.e., chronic psychotic spectrum disorders, clinically significant mood disorders) and/or one or more of the following: * evidence of active relapse or active impairing symptoms (e.g., suicidal ideation, audio or visual hallucinations, paranoia, thought disturbance, severe impairment) * evidence of minimal supports or limited adherence to ongoing mental health care * failure to provide comprehensive aftercare plan that includes emergency plan for addressing future mental health relapse * history of treatment refractory mental illness/recurrent relapse (multiple suicide attempts or inpatient psychiatric hospitalizations in the past 5 years) * within past 3 years: inpatient psychiatric hospitalization * within past 5 years: suicide attempt * declining to provide mental health records, a letter of support from mental health professionals, or consent for verbal consultation with mental health professionals when determined to be essential to evaluation. * cognitive impairment, if judged to have * limited capacity to make informed decision about procedure and inability to verbalize an understanding of the surgical procedure, risks and benefits. * inability to demonstrate an understanding of the permanency of lifestyle change required * history of anorexia or history of/active bulimia: if determined to be of low enough severity not to be a clear contraindication, minimum of 5 years abstinence from bulimia, current moderate to severe binge eating or night eating syndrome * active or history of substance abuse with less than 5 years of abstinence * current use of anti-tricyclic anti-depressants or steroids, psychiatric medications associated with weight gain.