Bariatric Arterial Embolization for Morbid Obesity (BAEMO)

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.

Study Overview

• Status: Unknown
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: left gastric artery embolization; Behavioral: healthy diet and exercise

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital,Southeast University
      • Contact: Zhibin Bai; Email: baizhibin1004@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Lipid Profile	Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
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.	post-op 30 days
Ghrelin levels	Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Abdominal fat content	Abdominal fat content detected by MRI.	Baseline, post-op 1 month,6 months,12 months
Leptin levels	Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Results of Gastroendoscopic Examination	Photos and clinical reports will be analyzed.	Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
Quality of Life Parameters Survey	N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.	12 months

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-jun Teng, Ph.D,MD, Zhongda Hospital Southeast University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 5, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: obesity; embolization; left gastric artery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2015ZDSYLL068.0