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

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ClinicalTrials.gov Identifier: NCT02165124
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
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

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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: Body Weight

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. 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%).


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

  2. 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

  3. 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.

  4. 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.


  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 Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (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, 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older 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 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

  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. 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.
  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 ClinicalTrials.gov identifier (NCT number): NCT02165124


Locations
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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
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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
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02165124     History of Changes
Other Study ID Numbers: NA_00093563
First Posted: June 17, 2014    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Johns Hopkins University:
Obesity
Morbid Obesity
Bariatric Surgery
Embolization
Minimally Invasive
Weight Loss
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms