Bariatric SurgeryNCT03732326
Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity
An observational study of Bariatric Surgery, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
This is a prospective cohort study which aims to explore the effect of bariatric surgery on cardiac and vascular structure and function in obesity. Enrolled patients will receive the following examinations before surgery and 3,6,12 month after the bariatric surgery: 24-h central and brachial ambulatory blood pressure… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2018to 24 Oct 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with morbid obesity, aged 15-65 years and without other severe diseases such as congestive heart failure, serious pulmonary and renal dysfunction and so forth.
Who may be able to join
- 15-65 years old
- conformed indication of Asian bariatric surgery (I.BMI≥32.5 or 27.5≤BMI<32.5 with obesity-related comorbidities )
- available for inspection and therapeutic schedule
- available for follow up
Who cannot join
- over 65 years old
- myocardial infarction, angina pectoris and ischemic stroke during the previous month
- congestive heart failure class IV based on the New York Heart Association classification
- malignancy or any other condition with poor prognosis
- serious pulmonary and renal dysfunction
- gastric disease
- poor compliance
- incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200072
Shikai Yu, +86 18801790211, shikaiyu@yahoo.com
About this study
This is a prospective cohort study which aims to explore the effect of bariatric surgery on cardiac and vascular structure and function in obesity. Enrolled patients will receive the following examinations before surgery and 3,6,12 month after the bariatric surgery: 24-h central and brachial ambulatory blood pressure monitoring, PWV, echocardiography, vascular endothelial function, hemodynamic including cardiac output and peripheral vascular resistance and so on. We compare these data before and after surgery in order to evaluate effectiveness of bariatric surgery in the cardiac and vascular structure and function.
Read the detailed description
The including citeria: 1)15-65 years old; 2) Indication for Asian bariatric surgery (I.BMI≥32.5 or 27.5≤BMI<32.5 with obesity-related comorbidities ) ;3) available for inspection and therapeutic schedule; 4) available for follow up. The excluding cteria: 1)over 65 years old; 2)myocardial infarction, angina pectoris and ischemic stroke during the previous month;3)congestive heart failure class IV based on the New York Heart Association classification; 4) malignancy or any other condition with poor prognosis; 5) serious pulmonary and renal dysfunction; 6) gastric disease; 7) poor compliance 8) incomplete clinical data .After enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight, waist circumference, hip circumference and so on; blood routine tests and biochemical tests. Every patient needs to be assessed before surgery and at 3,6,12 month by 24-h central and brachial ambulatory blood pressure, PWV, echocardiography, vascular endothelial function, cardiac output and peripheral vascular resistance. We compare these data before and after surgery in order to evaluate effectiveness of bariatric surgery in the vascular structure and function.
- Conditions
- Bariatric Surgery
- Being tested
- bariatric surgery
- Keywords
- Cardiac and Vascular Structure and Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
Bariatric surgery for enrolled patients who fulfill the including criteria
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular mass index
changes of left ventricular mass index representing cardiac structure measured by ultrasound will be seen from baseline at 1 year
Measured: 1 year
value of E and A peak
changes of value of E and A peak representing cardiac diastolic function measured by ultrasound will be seen from baseline at 1 year
Measured: 1 year
EF
changes of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year
Measured: 1 year
pulse wave velocity
changes of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year
Measured: 1 year
flow-mediated dilatation
changes of flow-mediated dilatation representing vascular function measured by UNEX EF will be seen from baseline at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start24 Oct 2018
- Primary completion24 Jan 2019 (estimated)
- Study completion24 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, MD, PhD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732326
- Sponsor's protocol ID
- B-VAS
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taegtmeyer H, Leichman JG, Reyes M, Lux TR. Early benefits from weight-loss surgery. J Am Coll Cardiol. 2010 Apr 20;55(16):1754; author reply 1754. doi: 10.1016/j.jacc.2009.11.081. No abstract available.
PubMed 20394883Rider OJ, Francis JM, Ali MK, Petersen SE, Robinson M, Robson MD, Byrne JP, Clarke K, Neubauer S. Beneficial cardiovascular effects of bariatric surgical and dietary weight loss in obesity. J Am Coll Cardiol. 2009 Aug 18;54(8):718-26. doi: 10.1016/j.jacc.2009.02.086.
PubMed 19679250Petersen KS, Clifton PM, Lister N, Keogh JB. Effect of weight loss induced by energy restriction on measures of arterial compliance: A systematic review and meta-analysis. Atherosclerosis. 2016 Apr;247:7-20. doi: 10.1016/j.atherosclerosis.2016.01.042. Epub 2016 Jan 29.
PubMed 26854971Ronggang P, Weilun M, Lei D, Shen Q, Yawei X, Changzheng G, Qizhong G, Xiaoyan W. Impact of weight loss on epicardial adipose tissue after laparoscopic sleeve gastrectomy: a CT-based quantitative analysis using ITK-SNAP. Surg Obes Relat Dis. 2025 Oct;21(10):1093-1100. doi: 10.1016/j.soard.2025.06.003. Epub 2025 Jun 18.
PubMed 40640018
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Cardiac and Vascular Structure and Function in Obesity
- ClinicalTrials.gov ID
- NCT03732326
- Acronym / sponsor ID
- B-VAS
- Conditions
- Bariatric Surgery
- Keywords
- Cardiac and Vascular Structure and Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 24 Jan 2019 (estimated)
- Study completion
- 24 Oct 2019 (estimated)
- First posted
- 6 Nov 2018 (actual)
- 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.
This is a prospective cohort study which aims to explore the effect of bariatric surgery on cardiac and vascular structure and function in obesity. Enrolled patients will receive the following examinations before surgery and 3,6,12 month after the bariatric surgery: 24-h central and brachial ambulatory blood pressure monitoring, PWV, echocardiography, vascular endothelial function, hemodynamic including cardiac output and peripheral vascular resistance and so on. We compare these data before and after surgery in order to evaluate effectiveness of bariatric surgery in the cardiac and vascular structure and function.
Detailed description
The including citeria: 1)15-65 years old; 2) Indication for Asian bariatric surgery (I.BMI≥32.5 or 27.5≤BMI<32.5 with obesity-related comorbidities ) ;3) available for inspection and therapeutic schedule; 4) available for follow up. The excluding cteria: 1)over 65 years old; 2)myocardial infarction, angina pectoris and ischemic stroke during the previous month;3)congestive heart failure class IV based on the New York Heart Association classification; 4) malignancy or any other condition with poor prognosis; 5) serious pulmonary and renal dysfunction; 6) gastric disease; 7) poor compliance 8) incomplete clinical data .After enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight, waist circumference, hip circumference and so on; blood routine tests and biochemical tests. Every patient needs to be assessed before surgery and at 3,6,12 month by 24-h central and brachial ambulatory blood pressure, PWV, echocardiography, vascular endothelial function, cardiac output and peripheral vascular resistance. We compare these data before and after surgery in order to evaluate effectiveness of bariatric surgery in the vascular structure and function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with morbid obesity, aged 15-65 years and without other severe diseases such as congestive heart failure, serious pulmonary and renal dysfunction and so forth.
Key inclusion criteria (4 listed)
- 15-65 years old
- conformed indication of Asian bariatric surgery (I.BMI≥32.5 or 27.5≤BMI<32.5 with obesity-related comorbidities )
- available for inspection and therapeutic schedule
- available for follow up
Key exclusion criteria (8 listed)
- over 65 years old
- myocardial infarction, angina pectoris and ischemic stroke during the previous month
- congestive heart failure class IV based on the New York Heart Association classification
- malignancy or any other condition with poor prognosis
- serious pulmonary and renal dysfunction
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 |
|---|---|---|
| bariatric surgeryBariatric surgery for enrolled patients who fulfill the including criteria | Procedure or surgery | – |
Primary outcome
left ventricular mass index
Time frame: 1 year
changes of left ventricular mass index representing cardiac structure measured by ultrasound will be seen from baseline at 1 year
value of E and A peak
Time frame: 1 year
changes of value of E and A peak representing cardiac diastolic function measured by ultrasound will be seen from baseline at 1 year
EF
Time frame: 1 year
changes of EF representing cardiac systolic function measured by ultrasound will be seen from baseline at 1 year
pulse wave velocity
Time frame: 1 year
changes of pulse wave velocity representing vascular structure measured by SphygmoCor will be seen from baseline at 1 year
flow-mediated dilatation
Time frame: 1 year
changes of flow-mediated dilatation representing vascular function measured by UNEX EF will be seen from baseline at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Results publication: PubMed 20394883Taegtmeyer H, Leichman JG, Reyes M, Lux TR. Early benefits from weight-loss surgery. J Am Coll Cardiol. 2010 Apr 20;55(16):1754; author reply 1754. doi: 10.1016/j.jacc.2009.11.081. No abstract available.
- Results publication: PubMed 19679250Rider OJ, Francis JM, Ali MK, Petersen SE, Robinson M, Robson MD, Byrne JP, Clarke K, Neubauer S. Beneficial cardiovascular effects of bariatric surgical and dietary weight loss in obesity. J Am Coll Cardiol. 2009 Aug 18;54(8):718-26. doi: 10.1016/j.jacc.2009.02.086.
- Results publication: PubMed 26854971Petersen KS, Clifton PM, Lister N, Keogh JB. Effect of weight loss induced by energy restriction on measures of arterial compliance: A systematic review and meta-analysis. Atherosclerosis. 2016 Apr;247:7-20. doi: 10.1016/j.atherosclerosis.2016.01.042. Epub 2016 Jan 29.
- Derived from this study: PubMed 40640018Ronggang P, Weilun M, Lei D, Shen Q, Yawei X, Changzheng G, Qizhong G, Xiaoyan W. Impact of weight loss on epicardial adipose tissue after laparoscopic sleeve gastrectomy: a CT-based quantitative analysis using ITK-SNAP. Surg Obes Relat Dis. 2025 Oct;21(10):1093-1100. doi: 10.1016/j.soard.2025.06.003. Epub 2025 Jun 18.
- Individual participant dataSharing planned: No
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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.
Yawei Xu, MD, PhD principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Shanghai 10th People's 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 4 inclusion and 8 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 6 Nov 2018. 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.
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 Shikai Yu, MD (+86 18801790211, shikaiyu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular mass index (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT03732326, which also lists 4 linked publications.
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 6 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.