Prediction Model for Inadequate Weight Loss After Sleeve... | NCT06157606

Studies
Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

NCT06157606

Sponsor

China-Japan Friendship Hospital

Status

Completed

Last Update Posted

Jul 8, 2025Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Bariatric Surgery
Sleeve Gastrectomy
Weight Loss

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Nov 27, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2025

Last Update Posted Date

Jul 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuntao Nie, Medical doctor, China-Japan Friendship HospitalPrincipal Investigator

Lead Sponsor

China-Japan Friendship HospitalOTHER

Collaborators

Name	Class
The Second Hospital of Shandong University	OTHER
Jining First People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuntao Nie, M.D.	China-Japan Friendship Hospital	Principal Investigator
Yinlu Ding, M.D.	The Second Hospital of Shandong University	Study Director
Ming Zhu, M.D.	Jining First People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuntao Nie		Beijing		100029	China

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided