Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03575988
Enrollment
180
Registered
2018-07-03
Start date
2018-07-03
Completion date
2019-06-03
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, Pulmonary function, Vascular endothelial function, Ultrasound

Brief 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.

Interventions

OTHERDiabetes

The patients have diabetes without diabetic retinopathy from the diabetic outpatient

Sponsors

Guanlin Yang
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pulmonary function parameters(diffusing capacity for carbon monoxide of lung/unit volume,DLCO/VA,%)one weekPulmonary 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.
pulmonary function parameters(forced expiratory volume in 1 second/ forced vital capacity,FEV1/FVC,%)one weekPulmonary 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.
pulmonary function parameters(vital capacity,VC,%)one weekPulmonary 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.
pulmonary function parameters(forced vital capacity,FVC,%)one weekPulmonary 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.
pulmonary function parameters(forced expiratory volume in 1 second,FEV1,%)one weekPulmonary 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.
pulmonary function parameters(peak expiratory force,PEF,%)one weekPulmonary 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.
pulmonary function parameters(maximal voluntary ventilation,MVV,%)one weekPulmonary 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.
pulmonary function parameters(total lung capacity,TLC,%)one weekPulmonary 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.
pulmonary function parameters(diffusing capacity for carbon monoxide of lung,DLCO,%)one weekPulmonary 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.

Secondary

MeasureTime frameDescription
Vascular endothelial function(nitrogen oxide,NO,μmol /L)one weekNO were detected by biochemical radioimmunoassay (biochemical,μmol /L),ET-1(radioimmunoassay,μg /L) were dectcted in sugar
Vascular endothelial function(endothelin-1,ET-1,μmol /L)one weekET-1 were detected by biochemical radioimmunoassay

Other

MeasureTime frameDescription
Serum lipid(Low-density lipoprotein cholesterol,LDL-C(mg/dl))on weekLDL-C were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.
Blood sugar(2-hour postprandial blood glucose , 2hPBG(mmol/l))one weekPlasma 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
Serum lipid(Total cholesterol,TC(mg/dl))on weekTC were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.
Blood sugar(glycosylated hemoglobinA1c,HbA1c(%))one weekPlasma 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
Serum lipid(Triglycerides,TG(mg/dl))on weekTG were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.
Blood sugar(fasting plasma glucose,FPG(mmol/l))one weekPlasma 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
Serum lipid(High-density lipoprotein cholesterol,HDL-C(mg/dl))on weekHDL-C were measured according to the research kit instructions. All the specimens were measured within 1 week of collection.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026