Trial record 1 of 53 for:    BEAT Obesity
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Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02165124
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : March 29, 2018
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Artificial Embolization Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bariatric Embolization of Arteries for the Treatment of Obesity
Study Start Date : June 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: Intervention/Bariatric Embolization Device: Artificial Embolization Device
Embosphere Microspheres
Other Names:
  • Device Product Codes: 85 NAJ
  • Classification Name: Artificial Embolization Device
  • Regulation Numbers: 21 CFR 882.5950

Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 12 Months ]
    Unit of Measure: Percentage of excess weight loss [%EWL]

Secondary Outcome Measures :
  1. Number of Patients with Adverse Events [ Time Frame: 30 Days ]

Other Outcome Measures:
  1. Blood pressure [ Time Frame: 12 Months ]
    Unit of Measure: mmHg

  2. Lipid Profile [ Time Frame: 12 Months ]
    Unit of Measure: mg/dL

  3. Ghrelin levels [ Time Frame: 12 Months ]
    Unit of Measure: pg/mL

  4. Serum obesity hormones [ Time Frame: 12 Months ]

    Examples of hormones to be tested:

    Leptin, GLP-1, PYY

    Unit of Measure: pg/mL

  5. Eating and hunger/satiety assessments [ Time Frame: 12 Months ]
    Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores

  6. Quality of Life Parameters Survey [ Time Frame: 12 Months ]
    Unit of Measure: N/A Utilizing SF-36 and IWQOL-Lite

  7. Food Intake [ Time Frame: 12 Months ]
    Documented via journal entries

  8. Results from Endoscopy [ Time Frame: 12 Months ]
    Photos and clinical reports analyzed

  9. Gastric Motility/Emptying [ Time Frame: 12 Months ]
    Unit of Measure: (t 1/2) in minutes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Willing, able and mentally competent to provide written informed consent.
  2. Body mass index (BMI) between 40-60.
  3. Residence within 25 miles of the enrolling institution
  4. 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.
  5. Suitable for protocol therapy as determined by the interventional radiology Investigator.
  6. Adequate hematological, hepatic and renal function as follows:

    Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR <1.5

    Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L

    Renal Estimated GFR > 60ml/min.1.73m2

  7. Aged 18 years or older.

Exclusion Criteria:

  1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery
  2. Prior radiation to the upper abdomen
  3. Prior embolization to the stomach, spleen or liver
  4. Portal venous hypertension
  5. Prior or current history of peptic ulcer disease
  6. Hiatal Hernia
  7. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
  8. Active H. Pylori infection
  9. Weight greater than 400 pound
  10. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute
  11. Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.
  12. 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.
  13. Pregnancy
  14. Preexisting chronic abdominal pain
  15. Positive stool occult study
  16. Abnormal Endoscopy
  17. Abnormal Nuclear Gastric Motility examination
  18. 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.
  19. History of Inflammatory Bowel Disease
  20. Autoimmune disease
  21. Cirrhosis
  22. Known history of allergy to iodinated contrast media

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02165124

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Icahn School of Medicine at Mount Sinai
Principal Investigator: Clifford R Weiss, M.D. Johns Hopkins University
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 - ; 212-241-7409
Study Chair: Ellen Weiss, B.S, M.A, M.S Icahn School of Medicine at Mount Sinai - ; 212-241-2317

Responsible Party: Johns Hopkins University Identifier: NCT02165124     History of Changes
Other Study ID Numbers: NA_00093563
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Johns Hopkins University:
Morbid Obesity
Bariatric Surgery
Minimally Invasive
Weight Loss

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms