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

• 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: Johns Hopkins University
• Collaborator: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Study Protocol and Statistical Analysis Plan  [PDF] December 17, 2015

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02165124 History of Changes
• Other Study ID Numbers: NA_00093563
• First Posted: June 17, 2014
• 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:

Obesity; Obesity, Morbid; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms