Lung Function in Bariatric Surgery Candidates

May 15, 2024 updated by: Yuntao Nie, China-Japan Friendship Hospital

The Impact of Body Mass Index on Lung Function in Bariatric Surgery Candidates

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1834

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China, 100029
        • Yuntao Nie

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

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

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
FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity
Time Frame: At the time of pulmonary function testing
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

Collaborators and Investigators

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

Sponsor

China-Japan Friendship Hospital

Investigators

  • Study Chair: Yuntao Nie, M.D., China-Japan Friendship 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 (Actual)

August 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CJBariatric006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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