The Research of Metabolomics on COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Correlation Research Between the Omega-3 and Omega-6 Inflammatory Metabolites and Stable COPD.

Conditions
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Metabolomics, Omega 6, Omega 3, COPD

Intervention / Treatment
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* 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.
* Diagnostic Test: Routine blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control<br>age - and sex-matched healthy individuals without lung disease | Diagnostic Test: Routine blood test<br>* Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.<br>|
| Patients with mild and moderate COPD<br>Grading according to the GOLD guide standards | Diagnostic Test: Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.<br>* This Jaeger lung function instrument of Germany is used to test the pulmonary ventilation function of COPD patients. Since the condition requires drug control and treatment, the drug cannot be stopped.<br>Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.<br>* We used the Agilent 1290 Infinity LC system mass spectrometer to analyze and detect metabolite peaks of patients according to retention time and mass/charge ratio after preliminary experiments and derivatization.<br>Diagnostic Test: Routine blood test<br>* Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.<br>|
| Patients with severe and very severe COPD<br>Grading according to the GOLD guide standards | Diagnostic Test: Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.<br>* This Jaeger lung function instrument of Germany is used to test the pulmonary ventilation function of COPD patients. Since the condition requires drug control and treatment, the drug cannot be stopped.<br>Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.<br>* We used the Agilent 1290 Infinity LC system mass spectrometer to analyze and detect metabolite peaks of patients according to retention time and mass/charge ratio after preliminary experiments and derivatization.<br>Diagnostic Test: Routine blood test<br>* Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.<br>|
| The severe and very severe COPD group baseline<br>Severe and very severe COPD patients were in the baseline time group | Diagnostic Test: Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.<br>* This Jaeger lung function instrument of Germany is used to test the pulmonary ventilation function of COPD patients. Since the condition requires drug control and treatment, the drug cannot be stopped.<br>Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.<br>* We used the Agilent 1290 Infinity LC system mass spectrometer to analyze and detect metabolite peaks of patients according to retention time and mass/charge ratio after preliminary experiments and derivatization.<br>Diagnostic Test: Routine blood test<br>* Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.<br>|
| The severe and very severe COPD group six months<br>Patients with severe and very severe COPD were six months from baseline. | Diagnostic Test: Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.<br>* This Jaeger lung function instrument of Germany is used to test the pulmonary ventilation function of COPD patients. Since the condition requires drug control and treatment, the drug cannot be stopped.<br>Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.<br>* We used the Agilent 1290 Infinity LC system mass spectrometer to analyze and detect metabolite peaks of patients according to retention time and mass/charge ratio after preliminary experiments and derivatization.<br>Diagnostic Test: Routine blood test<br>* Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.<br>|
| The severe and very severe COPD group one year<br>Patients with severe and very severe COPD were one year from baseline. | Diagnostic Test: Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.<br>* This Jaeger lung function instrument of Germany is used to test the pulmonary ventilation function of COPD patients. Since the condition requires drug control and treatment, the drug cannot be stopped.<br>Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.<br>* We used the Agilent 1290 Infinity LC system mass spectrometer to analyze and detect metabolite peaks of patients according to retention time and mass/charge ratio after preliminary experiments and derivatization.<br>Diagnostic Test: Routine blood test<br>* Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) | 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. | October 1, 2016 to October 1, 2018 | 
| Forced vital capacity (FVC) | 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. | October 1, 2016 to October 1, 2018 | 
| FEV1/FVC ratio | 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. | October 1, 2016 to October 1, 2018 | 
| The metabolites of Omega-6 inflammatory indicator | 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. | October 1, 2016 to October 1, 2018 | 
| The metabolites of Omega-3 inflammatory indicator | 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. | October 1, 2016 to October 1, 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reaction protein | 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. | October 1, 2016 to October 1, 2018 | 
| Leukocyte Count | 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. | October 1, 2016 to October 1, 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolomics, Omega 6, Omega 3, COPD, lung function tests