Diabetes Mellitus, Type 2NCT03575988
Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients
An observational study of Diabetes Mellitus, Type 2, run by Guanlin Yang.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2018to 3 Jun 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
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.
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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.
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About this study
Official title: Department of Solemn Scientific Research Platform in Liaoning University of Traditional Chinese Medicine
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
- Being tested
- Diabetes
- Keywords
- Type 2 diabetes, Pulmonary function, Vascular endothelial function, Ultrasound
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiabetesOther
The patients have diabetes without diabetic retinopathy from the diabetic outpatient
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group | Not described Receives: Other: Diabetes | |
| Control group | Not described Receives: Other: Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one week
Secondary outcomes (2)
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
Measured: one week
Vascular endothelial function(endothelin-1,ET-1,μmol /L)
ET-1 were detected by biochemical radioimmunoassay
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start3 Jul 2018 (estimated)
- Primary completion3 Nov 2018 (estimated)
- Study completion3 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Guanlin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guanlin Yang, Liaoning University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575988
- Sponsor's protocol ID
- 2018052802
- Status last verified
- Jun 2018
- First submitted
- 2 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33776922
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Solemn Scientific Research Platform in Liaoning University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT03575988
- Acronym / sponsor ID
- 2018052802
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, Pulmonary function, Vascular endothelial function, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guanlin YangUniversity, hospital or other
- Study start
- 3 Jul 2018 (estimated)
- Primary completion
- 3 Nov 2018 (estimated)
- Study completion
- 3 Jun 2019 (estimated)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes group | – | Other: Diabetes |
| Control group | – | Other: Diabetes |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiabetesThe patients have diabetes without diabetic retinopathy from the diabetic outpatient | Other | Control group, Diabetes group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Vascular endothelial function(nitrogen oxide,NO,μmol /L)
Time frame: one week
Vascular endothelial function(endothelin-1,ET-1,μmol /L)
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Derived from this study: PubMed 33776922Tai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Guanlin Yang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function parameters(vital capacity,VC,%) (time frame: one week). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.