NCT06157606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

7.1 years

First QC Date

November 27, 2023

Last Update Submit

July 4, 2025

Conditions

Bariatric SurgerySleeve GastrectomyWeight Loss

Keywords

Sleeve GastrectomyWeight LossPrediction Model

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Brier score of the prediction model

    1 year

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuntao Nie

Beijing, 100029, China

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 6, 2023

Study Start

September 1, 2017

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

CN(1)