The Research of Metabolomics on COPD

COPD Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042519
• Other study ID #: MG-201909
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: July 5, 2019

Study information

• Verified date: July 2019
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 5, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Metabolomics
• Omega 3
• Omega 6

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	the Fifth Affiliated Hospital of Zunyi Medical University

References & Publications (12)

D'Archivio M, Scazzocchio B, Giammarioli S, Fiani ML, Varì R, Santangelo C, Veneziani A, Iacovelli A, Giovannini C, Gessani S, Masella R. ?3-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. — View Citation

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. Review. — View Citation

Fulton AS, Hill AM, Williams MT, Howe PR, Frith PA, Wood LG, Garg ML, Coates AM. Feasibility of ?-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. — View Citation

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). pii: E666. doi: 10.3390/ijms19030666. — View Citation

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. — View Citation

Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigaré 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. Review. — View Citation

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. — View Citation

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). pii: E1864. doi: 10.3390/nu10121864. Review. — View Citation

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. Epub 2016 Sep 13. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%. ? level (moderate) : FEV1 / FVC < 70%, 50% ? FEV1% pred< 80%. ? 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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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