## Protocol Section
### Identification Module
**NCT ID:** NCT06421168

**Brief Title:** Lung Function in Bariatric Surgery Candidates

**Official Title:** The Impact of Body Mass Index on Lung Function in Bariatric Surgery Candidates

#### Organization Study ID Info
**ID:** CJBariatric006
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-08-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** China-Japan Friendship Hospital

#### Responsible Party

**Investigator Affiliation:** China-Japan Friendship Hospital

**Investigator Full Name:** Yuntao Nie

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### 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%.

### Conditions Module

**Conditions:**

- Lung Function Decreased

- Obesity

### Design Module

#### Design Info

**Observational Model:** CASE_CROSSOVER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1834

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity

**Time Frame:** At the time of pulmonary function testing

### 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).

**Minimum Age:** 16 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Bariatric surgery candidates who completed lung function tests preoperatively were enrolled.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Yuntao Nie

**Zip:** 100029

#### Overall Officials

**Official 1:**

**Affiliation:** China-Japan Friendship Hospital

**Name:** Yuntao Nie, M.D.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
