- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575988
Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients
Department of Solemn Scientific Research Platform in Liaoning University of Traditional Chinese Medicine
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.
Study Overview
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
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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.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
|
The patients have diabetes without diabetic retinopathy from the diabetic outpatient
|
Diabetes group
|
The patients have diabetes without diabetic retinopathy from the diabetic outpatient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pulmonary function parameters(vital capacity,VC,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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,%)
Time Frame: one week
|
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)
Time Frame: one week
|
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)
Time Frame: one week
|
ET-1 were detected by biochemical radioimmunoassay
|
one week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood sugar(2-hour postprandial blood glucose , 2hPBG(mmol/l))
Time Frame: one week
|
Plasma glucose levels were determined by the glucose oxidase method.
The OGTT method used 75 g of oral glucose (50% anhydrous glucose solution 150 ml including 7.5 bottles added to 150 ml warm water).
Venous blood was extracted to measure the 2hPG, and 5 ml of venous blood was placed into a glass tube, left standing at least 10 min, and centrifuged (3000 r/min) 10 min to separate serum, which was saved in -70 ℃ cryogenic refrigerator
|
one week
|
Blood sugar(fasting plasma glucose,FPG(mmol/l))
Time Frame: one week
|
Plasma glucose levels were determined by the glucose oxidase method.
The OGTT method used 75 g of oral glucose (50% anhydrous glucose solution 150 ml including 7.5 bottles added to 150 ml warm water).
Venous blood was extracted to measure the 2hPG, and 5 ml of venous blood was placed into a glass tube, left standing at least 10 min, and centrifuged (3000 r/min) 10 min to separate serum, which was saved in -70 ℃ cryogenic refrigerator
|
one week
|
Blood sugar(glycosylated hemoglobinA1c,HbA1c(%))
Time Frame: one week
|
Plasma glucose levels were determined by the glucose oxidase method.
The OGTT method used 75 g of oral glucose (50% anhydrous glucose solution 150 ml including 7.5 bottles added to 150 ml warm water).
Venous blood was extracted to measure the 2hPG, and 5 ml of venous blood was placed into a glass tube, left standing at least 10 min, and centrifuged (3000 r/min) 10 min to separate serum, which was saved in -70 ℃ cryogenic refrigerator
|
one week
|
Serum lipid(Total cholesterol,TC(mg/dl))
Time Frame: on week
|
TC were measured according to the research kit instructions.
All the specimens were measured within 1 week of collection.
|
on week
|
Serum lipid(High-density lipoprotein cholesterol,HDL-C(mg/dl))
Time Frame: on week
|
HDL-C were measured according to the research kit instructions.
All the specimens were measured within 1 week of collection.
|
on week
|
Serum lipid(Low-density lipoprotein cholesterol,LDL-C(mg/dl))
Time Frame: on week
|
LDL-C were measured according to the research kit instructions.
All the specimens were measured within 1 week of collection.
|
on week
|
Serum lipid(Triglycerides,TG(mg/dl))
Time Frame: on week
|
TG were measured according to the research kit instructions.
All the specimens were measured within 1 week of collection.
|
on week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018052802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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