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Bariatric Arterial Embolization for Morbid Obesity (BAEMO)

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ClinicalTrials.gov Identifier: NCT02786108
Recruitment Status : Unknown
Verified June 2016 by Gao-jun Teng, Zhongda Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: left gastric artery embolization Behavioral: healthy diet and exercise Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bariatric Arterial Embolization for Morbid Obesity
Study Start Date : May 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: left gastric artery embolization
Patients undergoing left gastric artery embolization
Procedure: left gastric artery embolization
Active Comparator: healthy diet and exercise
Patients undergoing healthy diet and exercise
Behavioral: healthy diet and exercise



Primary Outcome Measures :
  1. Weight Loss [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
    Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
    The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.

  2. Lipid Profile [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
    Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.

  3. Number of Patients with Adverse Events [ Time Frame: post-op 30 days ]
    Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.

  4. Ghrelin levels [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
    Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.

  5. Abdominal fat content [ Time Frame: Baseline, post-op 1 month,6 months,12 months ]
    Abdominal fat content detected by MRI.

  6. Leptin levels [ Time Frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months ]
    Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.

  7. Results of Gastroendoscopic Examination [ Time Frame: Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months ]
    Photos and clinical reports will be analyzed.

  8. Quality of Life Parameters Survey [ Time Frame: 12 months ]
    N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Body mass index (BMI) >30.
  2. No history of gastrointestinal surgery.
  3. Willing, able and mentally competent to provide written informed consent.
  4. Suitable for protocol therapy as determined by the interventional radiology Investigator.
  5. 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

  6. Aged between18 and 65 years old.
  7. More than one year's follow-up can be obtained reliably

Exclusion Criteria:

  1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery
  2. Prior embolization to the stomach, spleen or liver
  3. Prior or current history of peptic ulcer disease
  4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
  5. Portal venous hypertension or cirrhosis
  6. Less than 18 years or older than 65 years of age
  7. 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
  8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
  9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
  10. 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.
  11. Patients currently taking or requiring chronic use of NSAID or steroid medications

Information from the National Library of Medicine

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): NCT02786108


Contacts
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Contact: Zhibin Bai baizhibin1004@sina.com

Locations
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China, Jiangsu
Zhongda Hospital,Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Zhibin Bai       baizhibin1004@sina.com   
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Gao-jun Teng, Ph.D,MD Zhongda Hospital Southeast University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gao-jun Teng, Professor of Radiology & Chair,Department of Radiology, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT02786108     History of Changes
Other Study ID Numbers: 2015ZDSYLL068.0
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Keywords provided by Gao-jun Teng, Zhongda Hospital:
left gastric artery
embolization
obesity
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms