Morbid Obesity, Obesity, Weight Loss
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEBariatric Embolization of Arteries with imaging visible Embolics
bariatric embolization will be performed using tiny (100-200 μm), radiopaque (visible on X-ray) beads (referred to as BTG-001933) in order to suppress the body's signals for feeling hungry, which we predict will lead to weight loss.
Sponsors
Biocompatibles UK Ltd
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All participants in the pilot will receive study intervention
Intervention model description
Pilot study
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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\<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated glomerular filtration rate (GFR)\>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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (Pounds) | 12 months | Efficacy of Bariatric Embolization procedure assessed by change in body weight (pounds) |
| Change in Body Weight as Assessed by BMI (kg/m^2) | 12 months | Efficacy of Bariatric Embolization procedure assessed by change in body weight as assessed by BMI. |
Countries
United States
Participant flow
Recruitment details
Ten pilot patients were enrolled. Due to funding, the study was stopped after 10 pilot patients.
Participants by arm
| Arm | Count |
|---|---|
| Bariatric Embolization Procedure 10 subjects will be enrolled in the bariatric embolization(BM) pilot arm. BM procedure will be performed under moderate sedation. Procedure will take 1.5 hr to 3 hr subject will be placed on the X-ray fluoroscopy table. Radial or femoral vascular access will be achieved using a small gauge needle, dilated over a guidewire to accommodate a 5 French vascular sheath. Standard catheters, 3 dimensional imaging will be acquired of the stomach, the arteries supplying the fundus arising off the celiac vessel. Microcatheter into the left gastric and/or gastroepiploic arteries supplying the fundus and small calibrated spheres will be infused until stasis of anterograde arterial flow is achieved, with particular care to avoid infusion of non-target arteries. The left gastric and/or gastroepiploic arteries will be embolized. Repeat 3 dimensional imaging: assess bead distribution and fundal coverage. Subject will be monitored in the recovery room and will be observed overnight. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Bariatric Embolization Procedure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 38 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 3 / 10 |
Outcome results
Primary
Change in Body Weight as Assessed by BMI (kg/m^2)
Efficacy of Bariatric Embolization procedure assessed by change in body weight as assessed by BMI.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bariatric Embolization Procedure | Change in Body Weight as Assessed by BMI (kg/m^2) | 43.7 kg/m^2 | Standard Deviation 4.2 |
Primary
Change in Body Weight (Pounds)
Efficacy of Bariatric Embolization procedure assessed by change in body weight (pounds)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bariatric Embolization Procedure | Change in Body Weight (Pounds) | 14.3 pounds | Standard Deviation 22.5 |