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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Intervention/Bariatric Embolization||
Device: Artificial Embolization Device
- 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%).
- Blood Pressure [ Time Frame: 12 Months ]Unit of Measure: mmHg
- 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
- 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.
- 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.
- Eating and Hunger/Satiety Assessments [ Time Frame: 12 Months ]Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores
- 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
- Food Intake [ Time Frame: 12 Months ]Documented via journal entries
- Results From Endoscopy [ Time Frame: 12 Months ]Photos and clinical reports analyzed
- 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.
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
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|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 - firstname.lastname@example.org ; 212-241-7409|
|Study Chair:||Ellen Weiss, B.S, M.A, M.S||Icahn School of Medicine at Mount Sinai - email@example.com ; 212-241-2317|