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

Primary Purpose

Morbid Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Artificial Embolization Device

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Obesity, Morbid Obesity, Bariatric Surgery, Embolization, Minimally Invasive, Weight Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Willing, able and mentally competent to provide written informed consent.
Body mass index (BMI) between 40-60.
Residence within 25 miles of the enrolling institution
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.
Suitable for protocol therapy as determined by the interventional radiology Investigator.
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
Aged 18 years or older.

Exclusion Criteria:

Prior history of gastric pancreatic, hepatic, and/or splenic surgery
Prior radiation to the upper abdomen
Prior embolization to the stomach, spleen or liver
Portal venous hypertension
Prior or current history of peptic ulcer disease
Hiatal Hernia
Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
Active H. Pylori infection
Weight greater than 400 pound
Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute
Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.
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.
Pregnancy
Preexisting chronic abdominal pain
Positive stool occult study
Abnormal Endoscopy
Abnormal Nuclear Gastric Motility examination
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.
History of Inflammatory Bowel Disease
Autoimmune disease
Cirrhosis
Known history of allergy to iodinated contrast media

Sites / Locations

Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention/Bariatric Embolization

Arm Description

Outcomes

Primary Outcome Measures

Percent Weight Change

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%).

Secondary Outcome Measures

Full Information

NCT ID

NCT02165124

First Posted

June 11, 2014

Last Updated

November 1, 2018

Sponsor

Johns Hopkins University

Collaborators

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT02165124

Brief Title

Bariatric Embolization of Arteries for the Treatment of Obesity

Acronym

BEAT Obesity

Official Title

Bariatric Embolization of Arteries for the Treatment of Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

Keywords

Obesity, Morbid Obesity, Bariatric Surgery, Embolization, Minimally Invasive, Weight Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention/Bariatric Embolization

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Artificial Embolization Device

Other Intervention Name(s)

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

Intervention Description

Embosphere Microspheres

Primary Outcome Measure Information:

Title

Percent Weight Change

Description

Time Frame

12 Months

Other Pre-specified Outcome Measures:

Title

Blood Pressure

Description

Unit of Measure: mmHg

Time Frame

12 Months

Title

Lipid Panel

Description

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

Time Frame

12 Months

Title

Ghrelin Levels

Description

Unit of Measure: pg/mL, Ghrelin on the other hand is a fast-acting hormone, seemingly playing a role in meal initiation.

Time Frame

12 Months

Title

Serum Obesity Hormone(Leptin)

Description

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.

Time Frame

12 Months

Title

Eating and Hunger/Satiety Assessments

Description

Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores

Time Frame

12 Months

Title

Quality of Life Parameters Survey

Description

Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite

Time Frame

12 Months

Title

Food Intake

Description

Documented via journal entries

Time Frame

12 Months

Title

Results From Endoscopy

Description

Photos and clinical reports analyzed

Time Frame

12 Months

Title

Gastric Motility/Emptying

Description

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.

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing, able and mentally competent to provide written informed consent. Body mass index (BMI) between 40-60. Residence within 25 miles of the enrolling institution 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. Suitable for protocol therapy as determined by the interventional radiology Investigator. 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 Aged 18 years or older. Exclusion Criteria: Prior history of gastric pancreatic, hepatic, and/or splenic surgery Prior radiation to the upper abdomen Prior embolization to the stomach, spleen or liver Portal venous hypertension Prior or current history of peptic ulcer disease Hiatal Hernia Significant risk factors for peptic ulcer disease including daily NSAID use and smoking. Active H. Pylori infection Weight greater than 400 pound Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease. 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. Pregnancy Preexisting chronic abdominal pain Positive stool occult study Abnormal Endoscopy Abnormal Nuclear Gastric Motility examination 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. History of Inflammatory Bowel Disease Autoimmune disease Cirrhosis Known history of allergy to iodinated contrast media

Overall Study Officials: