Morbid ObesityPhase 3BAEMONCT02786108
Bariatric Arterial Embolization for Morbid Obesity
A Phase 3 study testing left gastric artery embolization and healthy diet and exercise in people with Morbid Obesity, run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- left gastric artery embolization and healthy diet and exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Zhibin Bai contact
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, 210009
Zhibin Bai, baizhibin1004@sina.com
About this study
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.
- Conditions
- Morbid Obesity
- Being tested
- left gastric artery embolization, healthy diet and exercise
- Keywords
- left gastric artery, embolization, obesity
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left gastric artery embolizationProcedure or surgery
healthy diet and exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| left gastric artery embolization | Experimental | Patients undergoing left gastric artery embolization Receives: Procedure: left gastric artery embolization |
| healthy diet and exercise | Active comparator | Patients undergoing healthy diet and exercise Receives: Behavioral: healthy diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast.
Measured: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Abdominal fat content
Abdominal fat content detected by MRI.
Measured: 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.
Measured: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Results of Gastroendoscopic Examination
Photos and clinical reports will be analyzed.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-jun Teng, Ph.D,MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786108
- Sponsor's protocol ID
- 2015ZDSYLL068.0
- Acronym
- BAEMO
- Status last verified
- Jun 2016
- First submitted
- 25 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29063494
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Arterial Embolization for Morbid Obesity
- ClinicalTrials.gov ID
- NCT02786108
- Acronym / sponsor ID
- BAEMO / 2015ZDSYLL068.0
- Conditions
- Morbid Obesity
- Keywords
- left gastric artery, embolization, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left gastric artery embolization | Experimental | Procedure: left gastric artery embolizationPatients undergoing left gastric artery embolization |
| healthy diet and exercise | Active comparator | Behavioral: healthy diet and exercisePatients undergoing healthy diet and exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left gastric artery embolization | Procedure or surgery | left gastric artery embolization |
| healthy diet and exercise | Behavioural | healthy diet and exercise |
Primary outcome
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.
8 secondary outcomes
Blood pressure
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Lipid Profile
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Number of Patients with Adverse Events
Time frame: post-op 30 days
Ghrelin levels
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Abdominal fat content
Time frame: Baseline, post-op 1 month,6 months,12 months
Leptin levels
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Results of Gastroendoscopic Examination
Time frame: Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
Quality of Life Parameters Survey
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Derived from this study: PubMed 29063494Bai 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.
Related trials for Morbid Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhibin Bai contact
Gao-jun Teng, Ph.D,MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing left gastric artery embolization and healthy diet and exercise in people with Morbid Obesity, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhibin Bai (baizhibin1004@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.