The Research of Metabolomics on COPD

NCT ID: NCT04042519

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-07-05

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.

Conditions

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Metabolomics Omega 6 Omega 3 COPD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Healthy control

age - and sex-matched healthy individuals without lung disease

Routine blood test

Intervention Type DIAGNOSTIC_TEST

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

Patients with mild and moderate COPD

Grading according to the GOLD guide standards

Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.

Intervention Type DIAGNOSTIC_TEST

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.

Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

Intervention Type DIAGNOSTIC_TEST

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.

Routine blood test

Intervention Type DIAGNOSTIC_TEST

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

Patients with severe and very severe COPD

Grading according to the GOLD guide standards

Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.

Intervention Type DIAGNOSTIC_TEST

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.

Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

Intervention Type DIAGNOSTIC_TEST

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.

Routine blood test

Intervention Type DIAGNOSTIC_TEST

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

The severe and very severe COPD group baseline

Severe and very severe COPD patients were in the baseline time group

Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.

Intervention Type DIAGNOSTIC_TEST

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.

Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

Intervention Type DIAGNOSTIC_TEST

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.

Routine blood test

Intervention Type DIAGNOSTIC_TEST

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

The severe and very severe COPD group six months

Patients with severe and very severe COPD were six months from baseline.

Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.

Intervention Type DIAGNOSTIC_TEST

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.

Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

Intervention Type DIAGNOSTIC_TEST

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.

Routine blood test

Intervention Type DIAGNOSTIC_TEST

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

The severe and very severe COPD group one year

Patients with severe and very severe COPD were one year from baseline.

Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.

Intervention Type DIAGNOSTIC_TEST

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.

Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

Intervention Type DIAGNOSTIC_TEST

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.

Routine blood test

Intervention Type DIAGNOSTIC_TEST

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

Interventions

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Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.

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.

Intervention Type DIAGNOSTIC_TEST

Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.

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.

Intervention Type DIAGNOSTIC_TEST

Routine blood test

Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Fifth Affiliated Hospital of Zunyi Medical College

OTHER

Sponsor Role collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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LuQian Zhou

Associate professor of respiratory medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Das UN. Ageing: Is there a role for arachidonic acid and other bioactive lipids? A review. J Adv Res. 2018 Feb 15;11:67-79. doi: 10.1016/j.jare.2018.02.004. eCollection 2018 May.

Reference Type BACKGROUND
PMID: 30034877 (View on PubMed)

Serkova NJ, Standiford TJ, Stringer KA. The emerging field of quantitative blood metabolomics for biomarker discovery in critical illnesses. Am J Respir Crit Care Med. 2011 Sep 15;184(6):647-55. doi: 10.1164/rccm.201103-0474CI. Epub 2011 Jun 16.

Reference Type BACKGROUND
PMID: 21680948 (View on PubMed)

Fulton AS, Hill AM, Williams MT, Howe PR, Frith PA, Wood LG, Garg ML, Coates AM. Feasibility of omega-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2013 Apr 24;14:107. doi: 10.1186/1745-6215-14-107.

Reference Type BACKGROUND
PMID: 23782589 (View on PubMed)

Tantucci C, Modina D. Lung function decline in COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:95-9. doi: 10.2147/COPD.S27480. Epub 2012 Feb 9.

Reference Type BACKGROUND
PMID: 22371650 (View on PubMed)

Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.

Reference Type BACKGROUND
PMID: 24787074 (View on PubMed)

D'Archivio M, Scazzocchio B, Giammarioli S, Fiani ML, Vari R, Santangelo C, Veneziani A, Iacovelli A, Giovannini C, Gessani S, Masella R. omega3-PUFAs exert anti-inflammatory activity in visceral adipocytes from colorectal cancer patients. PLoS One. 2013 Oct 7;8(10):e77432. doi: 10.1371/journal.pone.0077432. eCollection 2013.

Reference Type BACKGROUND
PMID: 24116229 (View on PubMed)

Lemoine S CM, Brigham EP, Woo H, Hanson CK, McCormack MC, Koch A, Putcha N, Hansel NN. Omega-3 fatty acid intake and prevalent respiratory symptoms among U.S. adults with COPD. BMC Pulm Med. 2019 May 21;19(1):97. doi: 10.1186/s12890-019-0852-4.

Reference Type BACKGROUND
PMID: 31122230 (View on PubMed)

Kilk K, Aug A, Ottas A, Soomets U, Altraja S, Altraja A. Phenotyping of Chronic Obstructive Pulmonary Disease Based on the Integration of Metabolomes and Clinical Characteristics. Int J Mol Sci. 2018 Feb 27;19(3):666. doi: 10.3390/ijms19030666.

Reference Type BACKGROUND
PMID: 29495451 (View on PubMed)

Wang Y, Xu J, Meng Y, Adcock IM, Yao X. Role of inflammatory cells in airway remodeling in COPD. Int J Chron Obstruct Pulmon Dis. 2018 Oct 12;13:3341-3348. doi: 10.2147/COPD.S176122. eCollection 2018.

Reference Type BACKGROUND
PMID: 30349237 (View on PubMed)

Pizzini A, Lunger L, Sonnweber T, Weiss G, Tancevski I. The Role of Omega-3 Fatty Acids in the Setting of Coronary Artery Disease and COPD: A Review. Nutrients. 2018 Dec 2;10(12):1864. doi: 10.3390/nu10121864.

Reference Type BACKGROUND
PMID: 30513804 (View on PubMed)

Mesaros C, Blair IA. Targeted chiral analysis of bioactive arachidonic Acid metabolites using liquid-chromatography-mass spectrometry. Metabolites. 2012 Apr 20;2(2):337-65. doi: 10.3390/metabo2020337.

Reference Type BACKGROUND
PMID: 24957514 (View on PubMed)

Schrimpe-Rutledge AC, Codreanu SG, Sherrod SD, McLean JA. Untargeted Metabolomics Strategies-Challenges and Emerging Directions. J Am Soc Mass Spectrom. 2016 Dec;27(12):1897-1905. doi: 10.1007/s13361-016-1469-y. Epub 2016 Sep 13.

Reference Type BACKGROUND
PMID: 27624161 (View on PubMed)

Other Identifiers

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MG-201909

Identifier Type: -

Identifier Source: org_study_id

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