MetabolomicsCOPDNCT04042519
The Research of Metabolomics on COPD
An observational study of Metabolomics and Omega 6, run by Guangzhou Institute of Respiratory Disease.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolomics, Omega 6, Omega 3
- What is being tested?
- Lung function test was performed on the subjects with Jaeger lung function instrument of Germany., Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection. and Routine blood test
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 5 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- COPD diagnosis
- The age ranges from 40 to 80
- No other pulmonary diseases
- No immune-related diseases
Who cannot join
- 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
About this study
Official title: The Correlation Research Between the Omega-3 and Omega-6 Inflammatory Metabolites and Stable COPD.
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.
Read the 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.
- Conditions
- Metabolomics, Omega 6, Omega 3, COPD
- Being tested
- Lung function test was performed on the subjects with Jaeger lung function instrument of Germany., Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection., Routine blood test
- Keywords
- Metabolomics, Omega 6, Omega 3, COPD, lung function tests
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Routine blood testDiagnostic test
Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | age - and sex-matched healthy individuals without lung disease Receives: Diagnostic Test: Routine blood test | |
| Patients with mild and moderate COPD | Grading according to the GOLD guide standards Receives: 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: October 1, 2016 to October 1, 2018
Secondary outcomes (2)
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.
Measured: 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.
Measured: October 1, 2016 to October 1, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Oct 2016
- Primary completion1 Oct 2018
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MetabolomicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- The Fifth Affiliated Hospital of Zunyi Medical College
- Responsible party
- Principal investigator, LuQian Zhou, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042519
- Sponsor's protocol ID
- MG-201909
- Acronym
- COPD
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In this study, smoking time data were also included. Next, we plan to grade smoking time or sick time(Time from baseline or from the time of first diagnosis) to evaluate the change trend of inflammation-related metabolites.
Publications
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.
PubMed 30034877Serkova 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.
PubMed 21680948Fulton 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.
PubMed 23782589Tantucci 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.
PubMed 22371650Maltais 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.
PubMed 24787074D'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.
PubMed 24116229Lemoine 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.
PubMed 31122230Kilk 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.
PubMed 29495451Wang 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.
PubMed 30349237Pizzini 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.
PubMed 30513804Mesaros 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.
PubMed 24957514Schrimpe-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.
PubMed 27624161
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Research Between the Omega-3 and Omega-6 Inflammatory Metabolites and Stable COPD.
- ClinicalTrials.gov ID
- NCT04042519
- Acronym / sponsor ID
- COPD / MG-201909
- Conditions
- Metabolomics, Omega 6, Omega 3, COPD
- Keywords
- Metabolomics, Omega 6, Omega 3, COPD, lung function tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- The Fifth Affiliated Hospital of Zunyi Medical College
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Diagnostic Test: Routine blood testage - and sex-matched healthy individuals without lung disease |
| Patients with mild and moderate COPD | – | 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 testGrading according to the GOLD guide standards |
| Patients with severe and very severe COPD | – | 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 testGrading according to the GOLD guide standards |
| The severe and very severe COPD group 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 testSevere and very severe COPD patients were in the baseline time group |
| The severe and very severe COPD group six months | – | 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 testPatients with severe and very severe COPD were six months from baseline. |
| The severe and very severe COPD group one year | – | 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 testPatients with severe and very severe COPD were one year from baseline. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- COPD diagnosis
- The age ranges from 40 to 80
- No other pulmonary diseases
- No immune-related diseases
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | 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.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. | Diagnostic test | 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 testBlood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al. | Diagnostic test | 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 |
Primary outcome
Forced expiratory volume in 1 second (FEV1)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
C-reaction protein
Time frame: October 1, 2016 to October 1, 2018
Leukocyte Count
Time frame: October 1, 2016 to October 1, 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 30034877Das 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.
- Background: PubMed 21680948Serkova 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.
- Background: PubMed 23782589Fulton 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.
- Background: PubMed 22371650Tantucci 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.
- Background: PubMed 24787074Maltais 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.
- Background: PubMed 24116229D'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.
- Background: PubMed 31122230Lemoine 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.
- Background: PubMed 29495451Kilk 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.
- Background: PubMed 30349237Wang 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.
- Background: PubMed 30513804Pizzini 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.
- Background: PubMed 24957514Mesaros 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.
- Background: PubMed 27624161Schrimpe-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.
- Individual participant dataSharing planned: Yes. In this study, smoking time data were also included. Next, we plan to grade smoking time or sick time(Time from baseline or from the time of first diagnosis) to evaluate the change trend of inflammation-related metabolites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolomics and Omega 6, run by Guangzhou Institute of Respiratory Disease.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in 1 second (FEV1) (time frame: October 1, 2016 to October 1, 2018). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042519, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.