The Research of Metabolomics on COPD

NCT04042519 | Completed

• 1 other identifier: MG-201909
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolomics; Omega 6; Omega 3; COPD

Keywords

Metabolomics; Omega 6; Omega 3; COPD; lung function tests

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• C-reaction protein

  October 1, 2016 to October 1, 2018

• Leukocyte Count

  October 1, 2016 to October 1, 2018

Study Arms (6)

Healthy control

age - and sex-matched healthy individuals without lung disease

Diagnostic Test: Routine blood test

Patients with mild and moderate COPD

Grading according to the GOLD guide standards

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

Patients with severe and very severe COPD

Grading according to the GOLD guide standards

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

The severe and very severe COPD group baseline

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.; Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.; Diagnostic Test: Routine blood test

The severe and very severe COPD group six months

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.; Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.; Diagnostic Test: Routine blood test

The severe and very severe COPD group one year

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.; Diagnostic Test: Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.; Diagnostic Test: Routine blood test

Interventions

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

Patients with mild and moderate COPD; Patients with severe and very severe COPD; The severe and very severe COPD group baseline; The severe and very severe COPD group one year; The severe and very severe COPD group six months

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

Patients with mild and moderate COPD; Patients with severe and very severe COPD; The severe and very severe COPD group baseline; The severe and very severe COPD group one year; The severe and very severe COPD group six months

Routine blood test DIAGNOSTIC_TEST

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

Healthy control; Patients with mild and moderate COPD; Patients with severe and very severe COPD; The severe and very severe COPD group baseline; The severe and very severe COPD group one year; The severe and very severe COPD group six months

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• The Fifth Affiliated Hospital of Zunyi Medical College: collaborator

Related Publications (12)

• 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.

  PMID: 30034877 BACKGROUND

• 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.

  PMID: 21680948 BACKGROUND

• 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.

  PMID: 23782589 BACKGROUND

• 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.

  PMID: 22371650 BACKGROUND

• 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.

  PMID: 24787074 BACKGROUND

• 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.

  PMID: 24116229 BACKGROUND

• 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.

  PMID: 31122230 BACKGROUND

• 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.

  PMID: 29495451 BACKGROUND

• 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.

  PMID: 30349237 BACKGROUND

• 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.

  PMID: 30513804 BACKGROUND

• 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.

  PMID: 24957514 BACKGROUND

• 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.

  PMID: 27624161 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of respiratory medicine

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 2, 2019
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: July 5, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: We will use the part of data for smoking-related research projects until 2020-06-01.
• Access Criteria: Patients aged 40 to 80 diagnosed with stable COPD according to diagnostic criteria were selected, regardless of gender. No lung tumor, no interstitial lung disease, no immune-related lung disease. The patient himself or his family signed the informed consent for the experiment.