Bariatric Arterial Embolization for Morbid Obesity (BAEMO)
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
left gastric artery embolization
healthy diet and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring left gastric artery, embolization, obesity
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) >30.
- No history of gastrointestinal surgery.
- Willing, able and mentally competent to provide written informed consent.
- 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 INR <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2
- Aged between18 and 65 years old.
- More than one year's follow-up can be obtained reliably
Exclusion Criteria:
- Prior history of gastric pancreatic, hepatic, and/or splenic surgery
- Prior embolization to the stomach, spleen or liver
- Prior or current history of peptic ulcer disease
- Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
- Portal venous hypertension or cirrhosis
- Less than 18 years or older than 65 years of age
- Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute an estimated glomerular filtration rate of < 60 milliliters per minute
- Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
- Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
- Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
- Patients currently taking or requiring chronic use of NSAID or steroid medications
Sites / Locations
- Zhongda Hospital,Southeast UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
left gastric artery embolization
healthy diet and exercise
Arm Description
Patients undergoing left gastric artery embolization
Patients undergoing healthy diet and exercise
Outcomes
Primary Outcome Measures
Weight Loss
Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.
Secondary Outcome Measures
Blood pressure
The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.
Lipid Profile
Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
Number of Patients with Adverse Events
Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.
Ghrelin levels
Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.
Abdominal fat content
Abdominal fat content detected by MRI.
Leptin levels
Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.
Results of Gastroendoscopic Examination
Photos and clinical reports will be analyzed.
Quality of Life Parameters Survey
N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02786108
Brief Title
Bariatric Arterial Embolization for Morbid Obesity
Acronym
BAEMO
Official Title
Bariatric Arterial Embolization for Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of left gastric artery embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight loss.
Although there are many ways to treat morbid obesity, surgery is currently the only effective method to be confirmed. But surgical treatment is likely to carry a high risk of treatment-related complications, such as fistula or intestinal obstruction, etc. This study is designed to help treat obesity using a method of transvascular interventional therapy, which is minimally invasive and non-surgical.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
left gastric artery, embolization, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
left gastric artery embolization
Arm Type
Experimental
Arm Description
Patients undergoing left gastric artery embolization
Arm Title
healthy diet and exercise
Arm Type
Active Comparator
Arm Description
Patients undergoing healthy diet and exercise
Intervention Type
Procedure
Intervention Name(s)
left gastric artery embolization
Intervention Type
Behavioral
Intervention Name(s)
healthy diet and exercise
Primary Outcome Measure Information:
Title
Weight Loss
Description
Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.
Time Frame
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.
Time Frame
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Title
Lipid Profile
Description
Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
Time Frame
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Title
Number of Patients with Adverse Events
Description
Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.
Time Frame
post-op 30 days
Title
Ghrelin levels
Description
Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.
Time Frame
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Title
Abdominal fat content
Description
Abdominal fat content detected by MRI.
Time Frame
Baseline, post-op 1 month,6 months,12 months
Title
Leptin levels
Description
Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.
Time Frame
Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Title
Results of Gastroendoscopic Examination
Description
Photos and clinical reports will be analyzed.
Time Frame
Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
Title
Quality of Life Parameters Survey
Description
N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) >30.
No history of gastrointestinal surgery.
Willing, able and mentally competent to provide written informed consent.
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 INR <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2
Aged between18 and 65 years old.
More than one year's follow-up can be obtained reliably
Exclusion Criteria:
Prior history of gastric pancreatic, hepatic, and/or splenic surgery
Prior embolization to the stomach, spleen or liver
Prior or current history of peptic ulcer disease
Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
Portal venous hypertension or cirrhosis
Less than 18 years or older than 65 years of age
Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute an estimated glomerular filtration rate of < 60 milliliters per minute
Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
Patients currently taking or requiring chronic use of NSAID or steroid medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhibin Bai
Email
baizhibin1004@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-jun Teng, Ph.D,MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhibin Bai
Email
baizhibin1004@sina.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
29063494
Citation
Bai ZB, Qin YL, Deng G, Zhao GF, Zhong BY, Teng GJ. Bariatric Embolization of the Left Gastric Arteries for the Treatment of Obesity: 9-Month Data in 5 Patients. Obes Surg. 2018 Apr;28(4):907-915. doi: 10.1007/s11695-017-2979-9.
Results Reference
derived
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Bariatric Arterial Embolization for Morbid Obesity
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