Skip to main content
OpenTrials
Completed

NCT Number: NCT04042519

The Research of Metabolomics on 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolomics COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Omega 3 Omega 6 Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 test

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. C-reaction protein

    Time frame: October 1, 2016 to October 1, 2018

    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.

  2. Leukocyte Count

    Time frame: October 1, 2016 to October 1, 2018

    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.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Collaborators

  • The Fifth Affiliated Hospital of Zunyi Medical College

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 2, 2019
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.