Metabolic SurgeryNCT03800160
Greater China Metabolic and Bariatric 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
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Apr 2029
- How long will I take part?
- 12 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, including but not limit to LSG and 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.
About this study
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, multicenter
- 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 different metabolic surgeries 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 different metabolic surgeries
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 level of metabolic surgery with long-time follow-ups
the change of HbA1c, glucose level, C-peptide and insulin levels
Measured: 1 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups
the change of HbA1c, glucose level, C-peptide and insulin levels
Measured: 3 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups
the change of HbA1c, glucose level, C-peptide and insulin levels
Measured: 5 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups
the change of HbA1c, glucose level, C-peptide and insulin levels
Measured: 10 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 Jan 2019
- Study start1 Apr 2018
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Hospital, Peking Union Medical College Hospital, Shanxi Dayi Hospital, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Inner Mongolia People's Hospital, Henan Provincial People's Hospital, Qilu Hospital of Shandong University, The First Hospital of Hebei Medical University, The Second People's Hospital of Xinxiang Henan, Tangshan Gongren Hospital, Tianjin Nankai Hospital, Tianjin First Central Hospital
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800160
- Sponsor's protocol ID
- GC-MBD
- Status last verified
- May 2024
- First submitted
- 14 May 2018
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greater China Metabolic and Bariatric Surgery Database
- ClinicalTrials.gov ID
- NCT03800160
- Acronym / sponsor ID
- GC-MBD
- Conditions
- Metabolic Surgery
- Keywords
- metabolic surgery, metabolic disease, multicenter
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Hospital, Peking Union Medical College Hospital, Shanxi Dayi Hospital, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Inner Mongolia People's Hospital, Henan Provincial People's Hospital, Qilu Hospital of Shandong University, The First Hospital of Hebei Medical University, The Second People's Hospital of Xinxiang Henan, Tangshan Gongren Hospital, Tianjin Nankai Hospital, Tianjin First Central Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 11 Jan 2019 (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
- 12 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, including but not limit to LSG and 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 different metabolic surgeries 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 different metabolic surgeries
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 level of metabolic surgery with long-time follow-ups
Time frame: 1 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups
Time frame: 3 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups
Time frame: 5 year after surgery
the glycemic control level of metabolic surgery with long-time follow-ups
Time frame: 10 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 13 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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: enrolling by invitation, as of the sponsor's last update on 13 May 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the excess weight loss effect of different metabolic surgeries 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?
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 13 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.