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Clinical Trials/NCT03152994
NCT03152994
Completed
Not Applicable

The Early Predictors,Neutrophil-lymphocyte Ratio (NLR), Platelet-lymphocyte Ratio (PLR) and Lymphocyte-monocyte Ratio (LMR) for Developing Type 2 Diabetes Mellitus in Stable Patients With Chronic Obstructive Pulmonary Disease

Zhujiang Hospital1 site in 1 country500 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Zhujiang Hospital
Enrollment
500
Locations
1
Primary Endpoint
fasting blood glucose(FBG)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Chronic obstructive pulmonary disease(COPD), characterized by persistent airflow limitation, associated with an progressive chronic inflammatory response of the lung to noxious particles or gases, can lead to dyspnea and limited mobility and influence the life quality of patients severely. Type 2 diabetes mellitus(T2DM), as a common complication of COPD, has got more attention in comprehensive control of COPD. Stress response and metabolic disorder are more likely to happen in COPD patients with T2DM in high level inflammation status, which decrease the drug efficacy, increase the risk of acute exacerbation of COPD, complications and mortality.

Both COPD and T2DM are chronic inflammatory disease with long term, there is close relationship in occurrence and development of each other, and the patients with severe COPD are more likely to develop T2DM. Monitoring the acute inflammation maker of C reactive protein (CRP) and IL-6(interleukin-6) is the most useable way to predict the inflammatory status and condition of COPD patient with T2DM, however the chronic inflammation maker is lacking. Neutrophil-to-Lymphocyte ratio(NLR), platelet-lymphocyte ratio (PLR) and lymphocyte-monocyte ratio (LMR) , the new, cheap and easy-tested chronic inflammatory markers, have got great research in early predicting the tumor such as nasopharyngeal carcinoma, soft tissue sarcoma and small-cell lung cancer,among them, NLR has manifest promising application in predicting insulin-resistance. However the value about NLR,PLR and LMR to predict the T2DM in COPD patients remain unknown and many articles related to NLR and COPD are retrospective.

The investigators attempt to analyze the risk factors and predict value of NLR,PLR and LMR about developing T2DM in COPD patients with prospective method.

Detailed Description

All the subjects will experience the follow-up every six months, accompanying the monitoring of fast blood glucose (FBG). The complete follow-up will span three years. The follow-up for one patient will stop early when its FBG≥7.0mmol/L which indicates the patient has developed new T2DM. The subjects will be divided into two groups according to whether patients develop T2DM at the end of each follow-up, namely, COPD patients with T2DM and COPD patients without T2DM

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
May 1, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The patients diagnosed with stable COPD but no T2DM between April 2017 to April 2020 at Zhu Jiang Hospital of Southern Medical University, will be included.
  • The diagnosis of COPD is according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Report.
  • T2DM diagnosis in accordance with the diagnostic criteria of WHO1999.

Exclusion Criteria

  • Patients will be excluded if they have other chronic or acute respiratory disease except COPD, such as bronchiectasia, lung tumor, interstitial pneumonia and hydrothorax; bilateral pulmonary multiple bullae; with metabolic disease such as T2DM, hyperthyroidism or hypothyroidism; questionnaire and laboratory dada was incomplete; with infection.

Outcomes

Primary Outcomes

fasting blood glucose(FBG)

Time Frame: Change from baseline in FBG(month 6, month 12, month 18, month 24, month 30, month 36)

FBG≥7.0mmol/L indicates the patient have developed new T2DM.

Secondary Outcomes

  • inspiratory muscle function(composite outcome measure)(For the patients who will develop T2DM during the follow up, to be tested at baseline and the time of outcome 1(FBG)≥7.0 (month 6, month 12, month 18, month 24, month 30 or month 36); For others, at baseline and the end of study(month 36))
  • routine blood parameters(composite outcome measure)(For the patients who will develop T2DM during the follow up, to be tested at baseline and the time of outcome 1(FBG)≥7.0 (month 6, month 12, month 18, month 24, month 30 or month 36); For others, at baseline and the end of study(month 36))
  • blood biochemistry(composite outcome measure)(For the patients who will develop T2DM during the follow up, to be tested at baseline and the time of outcome 1(FBG)≥7.0 (month 6, month 12, month 18, month 24, month 30 or month 36); For others, at baseline and the end of study(month 36))
  • Exercise capacity (composite outcome measure)(For the patients who will develop T2DM during the follow up, to be tested at baseline and the time of outcome 1(FBG)≥7.0 (month 6, month 12, month 18, month 24, month 30 or month 36); For others, at baseline and the end of study(month 36))

Study Sites (1)

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