The Early Predictors for Developing Type 2 Diabetes Mellitus in Patients With Chronic Obstructive Pulmonary Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Checking fasting blood glucose(FBG)

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

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

• Study Contact: Name: Liqing Wang, Doctor; Phone Number: +86-02062783391; Email: wliqing07@gmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Zhujiang Hospital,Southern Medical Universicity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients diagnosed with stable COPD but no T2DM between April 2017 to April 2020 at Zhujiang Hospital of Southern Medical University, will be included.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD patients with T2DM; For it's an observational study, fasting blood glucose(FBG) will be checked every six months. The patients who will develope T2DM during the follow-up will be divided into the group"COPD patients with T2DM".	Other: Checking fasting blood glucose(FBG); This is an observational study,fasting blood glucose(FBG) of each patient will be checked every six months.
COPD patients without T2DM; For it's an observational study, fasting blood glucose(FBG) will be checked every six months. The patients who won't develope T2DM during the follow-up will be divided into the group"COPD patients without T2DM".	Other: Checking fasting blood glucose(FBG); This is an observational study,fasting blood glucose(FBG) of each patient will be checked every six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose(FBG)	FBG≥7.0mmol/L indicates the patient have developed new T2DM.	Change from baseline in FBG(month 6, month 12, month 18, month 24, month 30, month 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
routine blood parameters（composite outcome measure）	The value of neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR) and lymphocyte-monocyte ratio (LMR) will be calculated by counting neutrophil, lymphocyte, platelet and monocyte in blood.	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)
inspiratory muscle function（composite outcome measure）	Currently, a variety of methods can be used to evaluate respiratory muscle function,including maximal inspiratory(PImax),expiratory pressures(PEmax)	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）	including HbA1c, triglycerides(TG), total cholesterol(TC), HDL-C, LDL-C, C-reactive protein(CRP), ESR(erythrocyte sedimentation rate), albumin.	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)	Exercise capacity is evaluated using the 6-min walking distance(6MWD) according to American Thoracic Society guidelines.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Evaluation(composite outcome measure)	Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness and psychological distress. Instruments for assessment of multiple symptoms include COPD Assessment Test(CAT) and Modified Medical British Research Council Scale(mMRC).	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)

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Xin Chen, Doctor, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Type 2 Diabetes Mellitus; neutrophil-lymphocyte ratio; platelet-lymphocyte ratio; lymphocyte-monocyte ratio
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Endocrine System Diseases; Disease Attributes; Chronic Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CX0422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No