Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity)
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.
We hope to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bariatric Embolization of Arteries for the Treatment of Obesity|
- Weight Loss [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: Percentage of excess weight loss [%EWL]
- Number of Patients with Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
- Blood pressure [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: mmHg
- Lipid Profile [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: mg/dL
- Ghrelin levels [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: pg/mL
- Serum obesity hormones [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Examples of hormones to be tested:
Leptin, GLP-1, PYY
Unit of Measure: pg/mL
- Eating and hunger/satiety assessments [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores
- Quality of Life Parameters Survey [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: N/A Utilizing SF-36 and IWQOL-Lite
- Food Intake [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Documented via journal entries
- Results from Endoscopy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Photos and clinical reports analyzed
- Gastric Motility/Emptying [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Unit of Measure: (t 1/2) in minutes
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
|Experimental: Intervention/Bariatric Embolization||
Device: Artificial Embolization Device
Please refer to this study by its ClinicalTrials.gov identifier: 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|