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

• ClinicalTrials.gov Identifier: NCT03575988
• Recruitment Status: Unknown
• First Posted: July 3, 2018
• Last Update Posted: July 3, 2018
• Sponsor: Guanlin Yang
• Information provided by (Responsible Party): Guanlin Yang, Liaoning University of Traditional Chinese Medicine

Study Description

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.

Condition or disease	Intervention/treatment
Diabetes Mellitus, Type 2	Other: Diabetes

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 180 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 3 Months
• Official Title: Department of Solemn Scientific Research Platform in Liaoning University of Traditional Chinese Medicine
• Estimated Study Start Date: July 3, 2018
• Estimated Primary Completion Date: November 3, 2018
• Estimated Study Completion Date: June 3, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Diabetes group	Other: Diabetes; The patients have diabetes without diabetic retinopathy from the diabetic outpatient
Control group	Other: Diabetes; The patients have diabetes without diabetic retinopathy from the diabetic outpatient

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.

Secondary Outcome Measures :

1. 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
2. Vascular endothelial function(endothelin-1,ET-1,μmol /L) [ Time Frame: one week ]
   ET-1 were detected by biochemical radioimmunoassay

Other Outcome Measures:

1. 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
2. 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
3. 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
4. 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.
5. 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.
6. 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.
7. 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.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

The diabetes duration (range 3 to 12 years), body mass index (range 23 to 31 kg/m2), glycosylated hemoglobin A1c levels [range 7.0% (53 mmol/mol) to 10% (86 mmol/mol)], pulmonary function parameters, retrobulbar hemodynamic parameters (bilateral resistivity index), serum lipid parameters (i.e., total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride), and blood pressure were recorded

Criteria

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.

-

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tai H, Jiang XL, Yao SC, Liu Y, Wei H, Li LB, Jiao ZJ, Wang TQ, Kuang JS, Jia LQ. Vascular Endothelial Function as a Valid Predictor of Variations in Pulmonary Function in T2DM Patients Without Related Complications. Front Endocrinol (Lausanne). 2021 Mar 11;12:622768. doi: 10.3389/fendo.2021.622768. eCollection 2021.

• Responsible Party: Guanlin Yang, Guan-lin Yang is the presidentg and full Clinical professor(Cardiovascular medicine) of Liaoning University of Traditional Chinese Medicine, Liaoning University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT03575988
• Other Study ID Numbers: 2018052802
• First Posted: July 3, 2018
• Last Update Posted: July 3, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guanlin Yang, Liaoning University of Traditional Chinese Medicine:

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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases