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Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Clifford R. Weiss, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02165124
First received: June 11, 2014
Last updated: September 7, 2016
Last verified: September 2016
  Purpose

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.

We hope to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.


Condition Intervention Phase
Morbid Obesity Device: Artificial Embolization Device Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bariatric Embolization of Arteries for the Treatment of Obesity

Further study details as provided by Clifford R. Weiss, Johns Hopkins University:

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


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

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

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

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

  • Serum obesity hormones [ Time Frame: 12 Months ]

    Examples of hormones to be tested:

    Leptin, GLP-1, PYY

    Unit of Measure: pg/mL


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

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

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

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

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


Estimated Enrollment: 20
Study Start Date: June 2014
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165124

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Icahn School of Medicine at Mount Sinai
Investigators
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 - 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
  More Information

Responsible Party: Clifford R. Weiss, Co-Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02165124     History of Changes
Other Study ID Numbers: NA_00093563
Study First Received: June 11, 2014
Last Updated: September 7, 2016

Keywords provided by Clifford R. Weiss, Johns Hopkins University:
Obesity
Morbid Obesity
Bariatric Surgery
Embolization
Minimally Invasive
Weight Loss

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

ClinicalTrials.gov processed this record on June 22, 2017