NCT06421168

Brief Summary

This study aims to retrospectively investigate the impact of body mass index on lung function metrics, e.g. FEV1%, FVC%, FEV1/FVC%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,834

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 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

6 years

First QC Date

May 13, 2024

Last Update Submit

May 15, 2024

Conditions

Lung Function DecreasedObesity

Outcome Measures

Primary Outcomes (1)

  • FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity

    Class 1 obesity: 27.5 kg/m2 \< body mass index \< 32.5 kg/m2; Class 2 obesity: 32.5 kg/m2 \< body mass index \< 37.5 kg/m2; Class 2 obesity: body mass index \> 37.5 kg/m2.

    At the time of pulmonary function testing

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bariatric surgery candidates who completed lung function tests preoperatively were enrolled.

You may qualify if:

  • Subjects with obesity (BMI ≥ 27.5 kg/m2 according to Chinese guidelines, guidelines from the American Society for Metabolic and Bariatric Surgery and International Federation for the Surgery of Obesity and Metabolic Disorders);
  • Age \> 16 years;
  • Complete preoperative pulmonary function tests

You may not qualify if:

  • Patients with a history of lung surgery and/or respiratory diseases (e.g. asthma, pulmonary emphysema, and interstitial pulmonary fibrosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuntao Nie

Beijing, 100029, China

Location

MeSH Terms

Conditions

Respiratory InsufficiencyObesity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuntao Nie, M.D.

    China-Japan Friendship Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 20, 2024

Study Start

September 1, 2017

Primary Completion

August 31, 2023

Study Completion

December 31, 2023

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)