Clinical trial NCT03575988: Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients
Official title: Department of Solemn Scientific Research Platform in Liaoning University of Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Pulmonary function
Vascular endothelial function
Ultrasound
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 180
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility 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.

-

Primary outcomes:
measure: pulmonary function parameters(vital capacity,VC,%)
timeFrame: one week
measure: pulmonary function parameters(forced vital capacity,FVC,%)
timeFrame: one week
measure: pulmonary function parameters(forced expiratory volume in 1 second,FEV1,%)
timeFrame: one week
measure: pulmonary function parameters(peak expiratory force,PEF,%)
timeFrame: one week
measure: pulmonary function parameters(maximal voluntary ventilation,MVV,%)
timeFrame: one week
measure: pulmonary function parameters(total lung capacity,TLC,%)
timeFrame: one week
measure: pulmonary function parameters(forced expiratory volume in 1 second/ forced vital capacity,FEV1/FVC,%)
timeFrame: one week
measure: pulmonary function parameters(diffusing capacity for carbon monoxide of lung,DLCO,%)
timeFrame: one week
measure: pulmonary function parameters(diffusing capacity for carbon monoxide of lung/unit volume,DLCO/VA,%)
timeFrame: one week
Secondary outcomes:
measure: Vascular endothelial function(nitrogen oxide,NO,μmol /L)
timeFrame: one week
measure: Vascular endothelial function(endothelin-1,ET-1,μmol /L)
timeFrame: one week
Other outcomes:
measure: Blood sugar(2-hour postprandial blood glucose , 2hPBG(mmol/l))
timeFrame: one week
measure: Blood sugar(fasting plasma glucose,FPG(mmol/l))
timeFrame: one week
measure: Blood sugar(glycosylated hemoglobinA1c,HbA1c(%))
timeFrame: one week
measure: Serum lipid(Total cholesterol,TC(mg/dl))
timeFrame: on week
measure: Serum lipid(High-density lipoprotein cholesterol,HDL-C(mg/dl))
timeFrame: on week
measure: Serum lipid(Low-density lipoprotein cholesterol,LDL-C(mg/dl))
timeFrame: on week
measure: Serum lipid(Triglycerides,TG(mg/dl))
timeFrame: on week
Locations:
Study officials:
References:
citation: 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.