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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03575988
• Other study ID #: 2018052802
• Status: Not yet recruiting
• Start date: July 3, 2018
• Est. completion date: June 3, 2019

Study information

• Verified date: June 2018
• Source: Liaoning University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 3, 2019
• Est. primary completion date: November 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Diabetes
The patients have diabetes without diabetic retinopathy from the diabetic outpatient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guanlin Yang

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood sugar(2-hour postprandial blood glucose , 2hPBG(mmol/l))	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
Other	Blood sugar(fasting plasma glucose,FPG(mmol/l))	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
Other	Blood sugar(glycosylated hemoglobinA1c,HbA1c(%))	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
Other	Serum lipid(Total cholesterol,TC(mg/dl))	TC were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.	on week
Other	Serum lipid(High-density lipoprotein cholesterol,HDL-C(mg/dl))	HDL-C were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.	on week
Other	Serum lipid(Low-density lipoprotein cholesterol,LDL-C(mg/dl))	LDL-C were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.	on week
Other	Serum lipid(Triglycerides,TG(mg/dl))	TG were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.	on week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Vascular endothelial function(endothelin-1,ET-1,µmol /L)	ET-1 were detected by biochemical radioimmunoassay	one week