Bariatric SurgeryNCT06157606
Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
An observational study of Bariatric Surgery and Sleeve Gastrectomy, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Bariatric Surgery, Sleeve Gastrectomy, Weight Loss
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Sep 2024
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population included patients with obesity who received sleeve gastrectomy between September 2017 and September 2024. All patients were followed up for at least 1 year.
Who may be able to join
- BMI ≥ 27.5 kg/m2;
- 16 years ≤ age ≤ 70 years;
- Complete preoperative data and one-year follow-up information
Who cannot join
- Patients who did not undergo SG;
- Incomplete follow-up information;
- Patients with a history of pituitary or thyroid disease;
- Female patients who conceived within one year after surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.
Read the detailed description
Inadequate weight loss (IWL) is a major problem after sleeve gastrectomy, leading to the recurrence of obesity-related comorbidities and increased risk of revision surgery. It is important to identify the high-risk individuals for IWL before surgery so that clinicians can initiate more rigorous weight monitoring and management strategies. Therefore, this study aims to develop a prediction model using preoperative clinical and laboratory data to estimate the risk of IWL one year after sleeve gastrectomy, and then validate it using two separate datasets.
- Conditions
- Bariatric Surgery, Sleeve Gastrectomy, Weight Loss
- Keywords
- Sleeve Gastrectomy, Weight Loss, Prediction Model
- Medical subject headings
- Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under receiver operating characteristic curve (AUC) of the prediction model
AUC reflects the discriminatory ability of the model, which was measured in this study.
Measured: 1 year
Secondary outcomes (1)
Brier score of the prediction model
Brier score reflects the calibration of the model, which was measured in this study.
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 Dec 2023
- Study start1 Sep 2017
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by China-Japan 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Shandong University, Jining First People's Hospital
- Responsible party
- Principal investigator, Yuntao Nie, China-Japan Friendship Hospital
- Investigators
- Yuntao Nie, M.D., Principal investigator, China-Japan Friendship HospitalYinlu Ding, M.D., Study director, The Second Hospital of Shandong UniversityMing Zhu, M.D., Study director, Jining First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157606
- Sponsor's protocol ID
- CJBariatric001
- Status last verified
- Jul 2025
- First submitted
- 27 Nov 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06157606
- Acronym / sponsor ID
- CJBariatric001
- Conditions
- Bariatric Surgery, Sleeve Gastrectomy, Weight Loss
- Keywords
- Sleeve Gastrectomy, Weight Loss, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- The Second Hospital of Shandong University, Jining First People's Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 Dec 2023 (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 study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.
Detailed description
Inadequate weight loss (IWL) is a major problem after sleeve gastrectomy, leading to the recurrence of obesity-related comorbidities and increased risk of revision surgery. It is important to identify the high-risk individuals for IWL before surgery so that clinicians can initiate more rigorous weight monitoring and management strategies. Therefore, this study aims to develop a prediction model using preoperative clinical and laboratory data to estimate the risk of IWL one year after sleeve gastrectomy, and then validate it using two separate datasets.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population included patients with obesity who received sleeve gastrectomy between September 2017 and September 2024. All patients were followed up for at least 1 year.
Key inclusion criteria (3 listed)
- BMI ≥ 27.5 kg/m2;
- 16 years ≤ age ≤ 70 years;
- Complete preoperative data and one-year follow-up information
Key exclusion criteria (4 listed)
- Patients who did not undergo SG;
- Incomplete follow-up information;
- Patients with a history of pituitary or thyroid disease;
- Female patients who conceived within one year after surgery
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
Area under receiver operating characteristic curve (AUC) of the prediction model
Time frame: 1 year
AUC reflects the discriminatory ability of the model, which was measured in this study.
1 secondary outcome
Brier score of the prediction model
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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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.
Yuntao Nie, M.D. principal investigator
China-Japan Friendship Hospital
Yinlu Ding, M.D. study director
The Second Hospital of Shandong University
Ming Zhu, M.D. study director
Jining First 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 and Sleeve Gastrectomy, run by China-Japan 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under receiver operating characteristic curve (AUC) of the prediction model (time frame: 1 year). 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 8 Jul 2025.