The Research of Metabolomics on COPD

Completed

• Conditions: Metabolomics; Omega 6; Omega 3; COPD
• Interventions: Diagnostic Test: Routine blood test; Diagnostic Test: Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.; Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

• Registration Number: NCT04042519
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

Targeted metabolomics research was conducted on patients with chronic obstructive pulmonary disease (COPD). The correlation analyst between inflammation-related metabolites and lung function was analyzed by explored the metabolic pathways of inflammation-related omega-6 and omega-3 and combining them with lung function.

Detailed Description

Based on the global initiative for chronic obstructive pulmonary disease, the 80 confirmed stable COPD patients with mild-to-moderate were involved, 80 COPD patients with severe and very severe, and age, sex, all matching 40 cases without lung disease. The participants information was collected. Whole blood and pulmonary function were examined at three time points: admission, six months and one year, at the same time, targeted metabolomic analysis method are applied to detect serum metabolites, According to the access to assess the different severity of COPD in the stable period and the level of metabolites in different admission periods. After that, correlation analysis was conducted with pulmonary function indicators and other clinical indicators to observe the research value of inflammation-related metabolites in the development of COPD.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2018-10-01
• Status Verified: 2019-07
• Study Completion: 2019-07-05
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-31
• Last Update Submitted: 2019-07-31
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• COPD diagnosis
• The age ranges from 40 to 80
• No other pulmonary diseases
• No immune-related diseases

Exclusion Criteria

• Not consistent with COPD diagnosis
• Age is out of range
• Interstitial lung disease, asthma and other lung diseases
• Immune system diseases
• Lost to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	Routine blood test	age - and sex-matched healthy individuals without lung disease
Patients with severe and very severe COPD	Routine blood test	Grading according to the GOLD guide standards
The severe and very severe COPD group six months	Routine blood test	Patients with severe and very severe COPD were six months from baseline.
Patients with mild and moderate COPD	Routine blood test	Grading according to the GOLD guide standards
Patients with severe and very severe COPD	Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.	Grading according to the GOLD guide standards
The severe and very severe COPD group baseline	Routine blood test	Severe and very severe COPD patients were in the baseline time group
The severe and very severe COPD group six months	Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.	Patients with severe and very severe COPD were six months from baseline.
The severe and very severe COPD group one year	Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.	Patients with severe and very severe COPD were one year from baseline.
The severe and very severe COPD group six months	Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.	Patients with severe and very severe COPD were six months from baseline.
The severe and very severe COPD group one year	Routine blood test	Patients with severe and very severe COPD were one year from baseline.
Patients with mild and moderate COPD	Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.	Grading according to the GOLD guide standards
Patients with severe and very severe COPD	Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.	Grading according to the GOLD guide standards
The severe and very severe COPD group baseline	Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.	Severe and very severe COPD patients were in the baseline time group
Patients with mild and moderate COPD	Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.	Grading according to the GOLD guide standards
The severe and very severe COPD group baseline	Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.	Severe and very severe COPD patients were in the baseline time group
The severe and very severe COPD group one year	Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.	Patients with severe and very severe COPD were one year from baseline.

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 second (FEV1)	October 1, 2016 to October 1, 2018	The FEV1 percentage of predicted value is an important indicator in the diagnosis and treatment of COPD, and plays an important role in the severity rating.; * level (mild) : FEV1 / FVC \< 70%, FEV1% pred \> 80%. Ⅱ level (moderate) : FEV1 / FVC \< 70%, 50% ≦ FEV1% pred\< 80%. Ⅲ level (severe) : FEV1 / FVC \< 70%, 30% ≦ FEV1% pred \< 50%. IV level (very severe) : FEV1/FVC\<70%, FEV1% pred \< 30%, or FEV1% pred \<50% with chronic respiratory failure.
Forced vital capacity (FVC)	October 1, 2016 to October 1, 2018	FVC is an important index to determine the resistance of respiratory tract. FEV1 and FEV1/FVC% in patients with obstructive airway obstruction, such as patients with chronic obstructive pulmonary disease, were reduced due to airway obstruction and prolonged expiratory.
FEV1/FVC ratio	October 1, 2016 to October 1, 2018	This index is an important basis for the diagnosis of COPD and is crucial in the early stage of the disease to the later stage of the evaluation.
The metabolites of Omega-6 inflammatory indicator	October 1, 2016 to October 1, 2018	Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for the targeted determination of metabolites in the serum of subjects.; Omega6 metabolites are closely related to inflammation and have been shown to be involved in a variety of diseases such as COPD, rheumatism, cardiovascular disease, et al.
The metabolites of Omega-3 inflammatory indicator	October 1, 2016 to October 1, 2018	As an important anti-inflammatory factor, omega-3 is widely used in chronic inflammatory diseases, which can fight against the pro-inflammatory metabolites of omega-6.

Secondary Outcome Measures

Name	Time	Method
C-reaction protein	October 1, 2016 to October 1, 2018	CRP is an acute phase protein synthesized by liver cells in response to inflammatory stimuli such as microbial invasion or tissue injury. Can reflect the inflammation level in COPD patients.
Leukocyte Count	October 1, 2016 to October 1, 2018	White blood cells are very important blood cells in human blood. White blood cells bear many important tasks in the human body. They have the function of swallowing foreign bodies and producing antibodies.