Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

December 4, 2023 updated by: Yuntao Nie, China-Japan Friendship Hospital
This study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100029
        • Recruiting
        • Yuntao Nie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuntao Nie, M.D.
        • Sub-Investigator:
          • Yinlu Ding, M.D.
        • Sub-Investigator:
          • Ming Zhu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • BMI ≥ 27.5 kg/m2;
  • 16 years ≤ age ≤ 70 years;
  • Complete preoperative data and one-year follow-up information

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brier score of the prediction model
Time Frame: 1 year
Brier score reflects the calibration of the model, which was measured in this study.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Collaborators

The Second Hospital of Shandong University
Shandong Jining No.1 People's Hospital

Investigators

  • Principal Investigator: Yuntao Nie, M.D., China-Japan Friendship Hospital
  • Study Director: Yinlu Ding, M.D., The Second Hospital of Shandong University
  • Study Director: Ming Zhu, M.D., Shandong Jining No.1 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJBariatric001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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