Chronic Obstructive Pulmonary DiseaseNCT03152994
The Early Predictors for Developing Type 2 Diabetes Mellitus in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Type 2 Diabetes Mellitus, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Type 2 Diabetes Mellitus
- What is being tested?
- Checking fasting blood glucose(FBG)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 1 May 2020
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universicity
Guangzhou, Guangdong, 510282
About this study
Official title: 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.
Read the 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
- Being tested
- Checking fasting blood glucose(FBG)
- Keywords
- Chronic Obstructive Pulmonary Disease, Type 2 Diabetes Mellitus, neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checking fasting blood glucose(FBG)Other
This is an observational study,fasting blood glucose(FBG) of each patient will be checked every six months.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Other: Checking fasting blood glucose(FBG) | |
| 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". Receives: Other: Checking fasting blood glucose(FBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose(FBG)
FBG≥7.0mmol/L indicates the patient have developed new T2DM.
Measured: Change from baseline in FBG(month 6, month 12, month 18, month 24, month 30, month 36)
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Apr 2017
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152994
- Sponsor's protocol ID
- CX0422
- Status last verified
- Apr 2017
- First submitted
- 1 May 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03152994
- Acronym / sponsor ID
- CX0422
- Keywords
- Chronic Obstructive Pulmonary Disease, Type 2 Diabetes Mellitus, neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 15 May 2017 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with T2DM | – | Other: Checking fasting blood glucose(FBG)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". |
| COPD patients without T2DM | – | Other: Checking fasting blood glucose(FBG)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". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Checking fasting blood glucose(FBG)This is an observational study,fasting blood glucose(FBG) of each patient will be checked every six months. | Other | COPD patients with T2DM, COPD patients without T2DM |
Primary outcome
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.
4 secondary outcomes
routine blood parameters（composite outcome measure）
Time frame: 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）
Time frame: 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）
Time frame: 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)
Time frame: 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)
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 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Xin Chen, Doctor principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Type 2 Diabetes Mellitus, run by Zhujiang Hospital at 1 site in China.
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 3 inclusion and 1 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
fasting blood glucose(FBG) (time frame: Change from baseline in FBG(month 6, month 12, month 18, month 24, month 30, month 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.