Lung Function in Bariatric Surgery Candidates | NCT06421168

Studies
Lung Function in Bariatric Surgery Candidates

NCT06421168

Sponsor

China-Japan Friendship Hospital

Status

Completed

Last Update Posted

May 20, 2024Actual

Enrollment

1,834Actual

Phase

Not provided

Conditions

Lung Function Decreased
Obesity

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

May 2024

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

Aug 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

May 13, 2024

First Submission Date that Met QC Criteria

May 15, 2024

First Posted Date

May 20, 2024Actual

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

May 15, 2024

Last Update Posted Date

May 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuntao Nie, Principal Investigator, China-Japan Friendship HospitalPrincipal Investigator

Lead Sponsor

China-Japan Friendship HospitalOTHER

Collaborators

Not provided

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,834Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuntao Nie, M.D.	China-Japan Friendship Hospital	Study Chair

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D009765	Obesity

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D050177	Overweight
D044343	Overnutrition

Browse Leaves

Not provided

Browse Branches

Not provided