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

NCT03575988 | Unknown DMC

• 1 other identifier: 2018052802
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Vascular endothelial function(nitrogen oxide,NO,μmol /L)

  one week

• Vascular endothelial function(endothelin-1,ET-1,μmol /L)

  one week

Other Outcomes (7)

• Blood sugar(2-hour postprandial blood glucose , 2hPBG(mmol/l))

  one week

• Blood sugar(fasting plasma glucose,FPG(mmol/l))

  one week

• Blood sugar(glycosylated hemoglobinA1c,HbA1c(%))

  one week

Study Arms (2)

Diabetes group

Other: Diabetes

Control group

Other: Diabetes

Interventions

Diabetes OTHER

The patients have diabetes without diabetic retinopathy from the diabetic outpatient

Control group; Diabetes group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

Sponsors & Collaborators

• Guanlin Yang: lead

Related Publications (1)

• 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.

  PMID: 33776922 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guan-lin Yang is the presidentg and full Clinical professor(Cardiovascular medicine) of Liaoning University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 3, 2018
• Study Start: July 3, 2018
• Primary Completion: November 3, 2018
• Study Completion: June 3, 2019
• Last Updated: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share