Clinical trial NCT02165124: Bariatric Embolization of Arteries for the Treatment of Obesity
Official title: Bariatric Embolization of Arteries for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Morbid Obesity
Bariatric Surgery
Embolization
Minimally Invasive
Weight Loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2014-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Weight Change
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
measure: Blood Pressure
timeFrame: 12 Months
measure: Lipid Panel
timeFrame: 12 Months
measure: Ghrelin Levels
timeFrame: 12 Months
measure: Serum Obesity Hormone(Leptin)
timeFrame: 12 Months
measure: Eating and Hunger/Satiety Assessments
timeFrame: 12 Months
measure: Quality of Life Parameters Survey
timeFrame: 12 Months
measure: Food Intake
timeFrame: 12 Months
measure: Results From Endoscopy
timeFrame: 12 Months
measure: Gastric Motility/Emptying
timeFrame: 12 Months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Clifford R Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Healthcare
name: Aravind Arepally, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Dara L Kraitchman, V.M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Lawrence Cheskin, M.D.
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai - aaron.fischman@mountsinai.org ; 212-241-7409
name: Aaron Fischman, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai - ellen.weiss@mountsinai.org ; 212-241-2317
name: Ellen Weiss, B.S, M.A, M.S
role: STUDY_CHAIR
References: