- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165124
Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity)
The purpose of this study is evaluate the safety and effectiveness of bariatric embolization as a minimally-invasive image-guided procedure for morbid obesity. In this procedure, specific blood vessels to the stomach are blocked in order to suppress some of the body's signals for feeling hungry, leading to weight loss.
Morbid obesity is currently treated with diet and exercise, medications, and surgery. This study is designed to help treat obesity using a minimally invasive, non-surgical, angiographic (through the blood vessel) approach. This procedure is similar to a common procedure used to treat bleeding within the stomach. This version of the procedure has been named "bariatric embolization".
Although there are over 40 hormones that limit food intake, there is only one hormone, ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has been a target for the treatment of obesity and weight loss. More recently, ghrelin has been shown to have a significant role in the long-term effect of weight loss in bariatric (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated patients.
Recent data collected in animals in has shown that blocking blood vessels to a particular portion of the stomach (bariatric embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5 people, there was a decrease in ghrelin levels and weight loss in the first month after the procedure, but there is no information about the effects of the procedure over longer periods of time.
The investigator hopes to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing, able and mentally competent to provide written informed consent.
- Body mass index (BMI) between 40-60.
- Residence within 25 miles of the enrolling institution
- Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.
- Suitable for protocol therapy as determined by the interventional radiology Investigator.
Adequate hematological, hepatic and renal function as follows:
Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L International Normalized Ratio (INR) <1.5
Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L
Renal Estimated Glomerular Filtration Rate (GFR) > 60ml/min.1.73m2
- Aged 18 years or older.
Exclusion Criteria:
- Prior history of gastric pancreatic, hepatic, and/or splenic surgery
- Prior radiation to the upper abdomen
- Prior embolization to the stomach, spleen or liver
- Portal venous hypertension
- Prior or current history of peptic ulcer disease
- Hiatal Hernia
- Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
- Active H. Pylori infection
- Weight greater than 400 pound
- Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute
- Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.
- Complicated arterial anatomic variants including left gastric artery arising from the aorta, and/or hepatic arterial supply via a replaced or accessory left hepatic artery arising from the left gastric artery.
- Pregnancy
- Preexisting chronic abdominal pain
- Positive stool occult study
- Abnormal Endoscopy
- Abnormal Nuclear Gastric Motility examination
- American Society of Anaesthesiologists (ASA) 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 will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects.
- History of Inflammatory Bowel Disease
- Autoimmune disease
- Cirrhosis
- Known history of allergy to iodinated contrast media
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention/Bariatric Embolization
|
Embosphere Microspheres
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Weight Change
Time Frame: 12 Months
|
This will be assessed by Percentage of excess weight loss (EWL).
Percentage of excess weight loss is calculated by measuring the participants excess weight at baseline and then calculating the percentage of excess weight that was lost 12 months after surgery (for example if a participant has 100 pounds of excess weight prior to surgery and loses 30 pounds, their excess weight loss would be 30%).
|
12 Months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: 12 Months
|
Unit of Measure: mmHg
|
12 Months
|
Lipid Panel
Time Frame: 12 Months
|
Unit of Measure: mg/dL, Total cholesterol, High-density lipoprotein cholesterol (HDL-C) - often called "good cholesterol" , Low-density lipoprotein cholesterol (LDL-C) - often called "bad cholesterol" and Triglycerides
|
12 Months
|
Ghrelin Levels
Time Frame: 12 Months
|
Unit of Measure: pg/mL, Ghrelin on the other hand is a fast-acting hormone, seemingly playing a role in meal initiation.
|
12 Months
|
Serum Obesity Hormone(Leptin)
Time Frame: 12 Months
|
This will be assessed by Leptin concentration Unit of Measure: pg/mL, Leptin is a mediator of long-term regulation of energy balance, suppressing food intake and thereby inducing weight loss. |
12 Months
|
Eating and Hunger/Satiety Assessments
Time Frame: 12 Months
|
Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores
|
12 Months
|
Quality of Life Parameters Survey
Time Frame: 12 Months
|
Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite
|
12 Months
|
Food Intake
Time Frame: 12 Months
|
Documented via journal entries
|
12 Months
|
Results From Endoscopy
Time Frame: 12 Months
|
Photos and clinical reports analyzed
|
12 Months
|
Gastric Motility/Emptying
Time Frame: 12 Months
|
Unit of Measure: (t 1/2) in minutes, A gastric emptying scan (GES) is a nuclear medicine exam that uses a radioactive material that you will eat in a meal. You will eat this meal in the Radiology department before your scan. The radioactive material allows doctors to see how your stomach empties. This scan is used to help diagnose conditions called motility disorders. These are conditions that change the way the stomach contracts and moves food into your intestines. A GES is a form of radiology, because radiation is used to take pictures of your body. |
12 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aravind Arepally, M.D., Piedmont Healthcare
- Principal Investigator: Dara L Kraitchman, V.M.D., Ph.D., Johns Hopkins University
- Study Chair: Lawrence Cheskin, M.D., Johns Hopkins University
- Principal Investigator: Aaron Fischman, M.D, Icahn School of Medicine at Mount Sinai - aaron.fischman@mountsinai.org ; 212-241-7409
- Study Chair: Ellen Weiss, B.S, M.A, M.S, Icahn School of Medicine at Mount Sinai - ellen.weiss@mountsinai.org ; 212-241-2317
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00093563
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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