Lung Function DecreasedNCT06421168
Lung Function in Bariatric Surgery Candidates
An observational study of Lung Function Decreased and Obesity, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aims to retrospectively investigate the impact of body mass index on lung function metrics, e.g. FEV1%, FVC%, FEV1/FVC%. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Function Decreased, Obesity
- How many people
- 1,834 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Bariatric surgery candidates who completed lung function tests preoperatively were enrolled.
Who may be able to join
- 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
Who cannot join
- Patients with a history of lung surgery and/or respiratory diseases (e.g. asthma, pulmonary emphysema, and interstitial pulmonary fibrosis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
- Conditions
- Lung Function Decreased, Obesity
- Medical subject headings
- Respiratory Insufficiency, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of pulmonary function testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Sep 2017
- Primary completion31 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Function DecreasedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1,834 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuntao Nie, China-Japan Friendship Hospital
- Investigators
- Yuntao Nie, M.D., Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421168
- Sponsor's protocol ID
- CJBariatric006
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Body Mass Index on Lung Function in Bariatric Surgery Candidates
- ClinicalTrials.gov ID
- NCT06421168
- Acronym / sponsor ID
- CJBariatric006
- Conditions
- Lung Function Decreased, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,834 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to retrospectively investigate the impact of body mass index on lung function metrics, e.g. FEV1%, FVC%, FEV1/FVC%.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Bariatric surgery candidates who completed lung function tests preoperatively were enrolled.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a history of lung surgery and/or respiratory diseases (e.g. asthma, pulmonary emphysema, and interstitial pulmonary fibrosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuntao Nie, M.D. study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function Decreased and Obesity, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity (time frame: At the time of pulmonary function testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.