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临床试验/NCT04042519
NCT04042519已完成不适用

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

Guangzhou Institute of Respiratory Disease0 个研究点目标入组 200 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
主要终点
Forced expiratory volume in 1 second (FEV1)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Forced expiratory volume in 1 second (FEV1)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • C-reaction protein(October 1, 2016 to October 1, 2018)
  • Leukocyte Count(October 1, 2016 to October 1, 2018)

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

LuQian Zhou

Associate professor of respiratory medicine

Guangzhou Institute of Respiratory Disease

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