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

November 1, 2018 updated by: Johns Hopkins University

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Device Product Codes: 85 NAJ
  • Classification Name: Artificial Embolization Device
  • Regulation Numbers: 21 CFR 882.5950

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

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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