Morbid Obesity
Conditions
Keywords
Obesity, Morbid Obesity, Bariatric Surgery, Embolization, Minimally Invasive, Weight Loss
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.
Interventions
DEVICEArtificial Embolization Device
Embosphere Microspheres
Sponsors
Icahn School of Medicine at Mount Sinai
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change | 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
| Measure | Time frame | Description |
|---|---|---|
| Lipid Panel | 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 | 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) | 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 | 12 Months | Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores |
| Blood Pressure | 12 Months | Unit of Measure: mmHg |
| Food Intake | 12 Months | Documented via journal entries |
| Results From Endoscopy | 12 Months | Photos and clinical reports analyzed |
| Gastric Motility/Emptying | 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. |
| Quality of Life Parameters Survey | 12 Months | Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention/Bariatric Embolization Artificial Embolization Device: Embosphere Microspheres | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intervention/Bariatric Embolization |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 8 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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%).
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention/Bariatric Embolization | Percent Weight Change | 11.5 percentage of excess weight loss | Standard Deviation 10.2 |
Other Pre-specified
Blood Pressure
Unit of Measure: mmHg
Time frame: 12 Months
Other Pre-specified
Eating and Hunger/Satiety Assessments
Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores
Time frame: 12 Months
Other Pre-specified
Food Intake
Documented via journal entries
Time frame: 12 Months
Other Pre-specified
Gastric Motility/Emptying
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
Other Pre-specified
Ghrelin Levels
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
Other Pre-specified
Lipid Panel
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
Other Pre-specified
Quality of Life Parameters Survey
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
Other Pre-specified
Results From Endoscopy
Photos and clinical reports analyzed
Time frame: 12 Months
Other Pre-specified
Serum Obesity Hormone(Leptin)
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