Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients

Study Overview
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Brief Summary
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Current knowledge: To the best of our knowledge, no studies have reported the correlation between pulmonary function and the vascular endothelial function in diabetic patients during the preclinical period. Indeed, diabetic nephropathy and retinopathy are the leading causes of end-stage renal failure and acquired blindness, respectively. However, when investigators treat patients with type 2 diabetes, investigators seldom consider the pulmonary vascular injury induced by glycemia. Experimental studies have shown that pulmonary function and Vascular endothelial function change during the preclinical stages of diabetic retinopathy. Researchers have already established that compared to healthy subjects, patients with type 2 diabetes have a reduced alveolar gas exchange capacity. The NO and ET-1 can be used to assess the Vascular endothelial function. What this paper contributes to our knowledge: Regulating glycemia can improve Vascular endothelial function . This study suggests that detecting the NO and ET-1 would allow for the prediction of changes in pulmonary function during the preclinical stages of diabetic retinopathy and the degree of retinopathy in the future.

Official Title
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Department of Solemn Scientific Research Platform in Liaoning University of Traditional Chinese Medicine

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:1) symptoms of diabetes (thirst, polydipsia, diuresis, and unexplainable weight loss); 2) random blood sugar ≥11.1 mol/L, fasting plasma glucose ≥7.0 mol/L or an oral glucose tolerance test outcome (2-hour postprandial blood glucose) ≥11.1 mol/L; or 3) no symptoms of diabetes but either random blood sugar ≥11.1 mol/L or fasting plasma glucose ≥7.0 mol/L. - Exclusion Criteria:1) diagnosis of type 2 diabetes according to the guidelines of the American Diabetes Association;11 2) no history of smoking (never smoked), pulmonary disease or pulmonary infection (during the treatment or recovery period); 3) no hepatopathy, nephropathy, or gastrointestinal disease; and 4) a high likelihood of good compliance and the ability to visit our hospital for periodic assessments. The exclusion criteria were as follows: 1) diagnosis of type 1 diabetes; 2) pregnancy and/or active lactation; 3) intensive care with insulin treatment; 4) renal inadequacy, hypohepatia, or heart disease; 5) pneumonia, influenza (during the treatment or recovery period), phthisis or other pulmonary infection; 6) presence of multiple pulmonary cysts, bullae of the lung, or diffuse pulmonary calcifications confirmed via CT; 7) combined diabetic retinopathy and hypertension (for which antihypertensive drugs are used); 8) aneurysm, dissection of aorta; 9) inadequate control of serum lipid parameters by cholesterol-lowering drugs; 10) body mass index ≥32; and 11) the use of systemically injected glucocorticoids within 3 months prior to our study. -

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes group<br> | Other: Diabetes<br>* The patients have diabetes without diabetic retinopathy from the diabetic outpatient<br>|
| Control group<br> | Other: Diabetes<br>* The patients have diabetes without diabetic retinopathy from the diabetic outpatient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function parameters(vital capacity,VC,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(forced vital capacity,FVC,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(forced expiratory volume in 1 second,FEV1,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(peak expiratory force,PEF,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(maximal voluntary ventilation,MVV,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(total lung capacity,TLC,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(forced expiratory volume in 1 second/ forced vital capacity,FEV1/FVC,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(diffusing capacity for carbon monoxide of lung,DLCO,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 
| pulmonary function parameters(diffusing capacity for carbon monoxide of lung/unit volume,DLCO/VA,%) | Pulmonary function tests were performed using a spirometer. We used the ratio of measured values to the expected values, % of predicted value, to eliminate the influence of age, height, and weight. Before testing, subjects remained sitting at quiet rest for at least 30 min, pulmonary function tests were performed 3 times and the best of 3 acceptable readings was used in the analysis. Spirometry and analysis of pulmonary function were performed by trained professionals. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular endothelial function(nitrogen oxide,NO,μmol /L) | NO were detected by biochemical radioimmunoassay (biochemical,μmol /L),ET-1(radioimmunoassay,μg /L) were dectcted in sugar | one week | 
| Vascular endothelial function(endothelin-1,ET-1,μmol /L) | ET-1 were detected by biochemical radioimmunoassay | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Pulmonary function, Vascular endothelial function, Ultrasound