Metabolic SurgeryNCT03520699
Beijing Friendship Hospital Metabolic Surgery Database
An observational study of Metabolic Surgery, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Surgery
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with morbid obesity who are suitable and willing to accept metabolic surgical procedure and also agree with the registry
Who may be able to join
- be able to receive metabolic surgery (LSG or LRYGB)
Who cannot join
- can not be able to understand and willing to participate in this registry with signature
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing
Zhongtao Zhang, M.D., +86-13801060364, zhangzht@ccmu.edu.cn
About this study
Official title: Beijing Friendship Hospital Metabolic Surgery Clinical Database
Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.
- Conditions
- Metabolic Surgery
- Keywords
- metabolic surgery, metabolic disease
- Medical subject headings
- Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
the excess weight loss effect of metabolic surgery after 1year
Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
Measured: 1 year after surgery
Secondary outcomes (8)
the adverse events rate of metabolic surgery
show the surgical safety by 30 days follow-up according to guideline（such as: bleeding, leak, obstruction, re-operation for complication）
Measured: 30 days after surgery
the excess weight loss effect of metabolic surgery with long-time follow-ups
Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
Measured: 3 years
the excess weight loss effect of metabolic surgery with long-time follow-ups
Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
Measured: 5 years
the excess weight loss effect of metabolic surgery with long-time follow-ups
Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
Measured: 10 years
the glycemic control effect of metabolic surgery with long-time follow-ups
the decrease of HbA1c, glucose level, C-peptide and insulin levels
Measured: 3 years
the glycemic control effect of metabolic surgery with long-time follow-ups
the decrease of HbA1c, glucose level, C-peptide and insulin levels
Measured: 5 years
the glycemic control effect of metabolic surgery with long-time follow-ups
the decrease of HbA1c, glucose level, C-peptide and insulin levels
Measured: 10 years
the glycemic control effect of metabolic surgery after 1 year
the decrease of HbA1c, glucose level, C-peptide and insulin levels
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SurgeryStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520699
- Sponsor's protocol ID
- BFH-MSD
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lv H, Li M, Liu Y, Zhao L, Sun J, Cao D, Zeng N, Liu J, Liu Y, Bian S, Zhang P, Yang Z, Zhang Z, Wang Z. The Clinical Value and Appropriateness Criteria of Upper Abdominal Magnetic Resonance Examinations in Patients Before and After Bariatric Surgery: a Study of 837 Images. Obes Surg. 2020 Oct;30(10):3784-3791. doi: 10.1007/s11695-020-04688-w.
PubMed 32483745Zhang P, Liu Y, Lv H, Li MY, Yu FX, Wang Z, Ding HY, Wang LX, Zhao KX, Zhang ZY, Zhao PF, Li J, Yang ZH, Zhang ZT, Wang ZC. Integration of Neural Reward Processing and Appetite-Related Signaling in Obese Females: Evidence From Resting-State fMRI. J Magn Reson Imaging. 2019 Aug;50(2):541-551. doi: 10.1002/jmri.26576. Epub 2019 Jan 17.
PubMed 30653786
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Friendship Hospital Metabolic Surgery Clinical Database
- ClinicalTrials.gov ID
- NCT03520699
- Acronym / sponsor ID
- BFH-MSD
- Conditions
- Metabolic Surgery
- Keywords
- metabolic surgery, metabolic disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 May 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.
Metabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with morbid obesity who are suitable and willing to accept metabolic surgical procedure and also agree with the registry
Key inclusion criteria (1 listed)
- be able to receive metabolic surgery (LSG or LRYGB)
Key exclusion criteria (1 listed)
- can not be able to understand and willing to participate in this registry with signature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the excess weight loss effect of metabolic surgery after 1year
Time frame: 1 year after surgery
Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2)
8 secondary outcomes
the adverse events rate of metabolic surgery
Time frame: 30 days after surgery
the excess weight loss effect of metabolic surgery with long-time follow-ups
Time frame: 3 years
the excess weight loss effect of metabolic surgery with long-time follow-ups
Time frame: 5 years
the excess weight loss effect of metabolic surgery with long-time follow-ups
Time frame: 10 years
the glycemic control effect of metabolic surgery with long-time follow-ups
Time frame: 3 years
the glycemic control effect of metabolic surgery with long-time follow-ups
Time frame: 5 years
the glycemic control effect of metabolic surgery with long-time follow-ups
Time frame: 10 years
the glycemic control effect of metabolic surgery after 1 year
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 32483745Lv H, Li M, Liu Y, Zhao L, Sun J, Cao D, Zeng N, Liu J, Liu Y, Bian S, Zhang P, Yang Z, Zhang Z, Wang Z. The Clinical Value and Appropriateness Criteria of Upper Abdominal Magnetic Resonance Examinations in Patients Before and After Bariatric Surgery: a Study of 837 Images. Obes Surg. 2020 Oct;30(10):3784-3791. doi: 10.1007/s11695-020-04688-w.
- Derived from this study: PubMed 30653786Zhang P, Liu Y, Lv H, Li MY, Yu FX, Wang Z, Ding HY, Wang LX, Zhao KX, Zhang ZY, Zhao PF, Li J, Yang ZH, Zhang ZT, Wang ZC. Integration of Neural Reward Processing and Appetite-Related Signaling in Obese Females: Evidence From Resting-State fMRI. J Magn Reson Imaging. 2019 Aug;50(2):541-551. doi: 10.1002/jmri.26576. Epub 2019 Jan 17.
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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.
Zhongtao Zhang, M.D. principal investigator
Beijing Friendship 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 Metabolic Surgery, run by Beijing Friendship 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Sep 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongtao Zhang, M.D. (+86-13801060364, zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the excess weight loss effect of metabolic surgery after 1year (time frame: 1 year after surgery). 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 NCT03520699, which also lists 2 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 10 Sep 2019.