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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06421168
Other study ID # CJBariatric006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 31, 2023

Study information

Verified date May 2024
Source China-Japan Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1834
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yuntao Nie Beijing

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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