Lung Function in Bariatric Surgery Candidates

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06421168
• Other study ID #: CJBariatric006
• Status: Completed
• 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
• 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
• 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).

Related Conditions & MeSH terms

• Lung Function Decreased
• Obesity

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