Diabetes Mellitus, Type 2CPCT2DMNCT02774733
Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters (PSV, EDV, RI) of Retrobulbar Blood Vessels (CRA, PCA, and OA) in 48 T2DM Patients Did Not Combinate With DR
An observational study of Diabetes Mellitus, Type 2, run by Fourth People's Hospital of Shenyang.
Trial summary
Objective: The main target of this study was to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients with type 2 diabetes (T2DM) without diabetic retinopathy (DR). Read more about this study
- Who is it for?
- Ages 34 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- spirometer;Intraocular pressure;Color doppler imaging
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Apr 2016
- 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 34 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Investigators selected 60 patients (34 males, 26 females) with T2DM from the the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 48 patients (26 males, 22 females) can be researched in our study. All patients were provided a diet and exercise program by professional nutritionists. The race ratio (all were Chinese Hans), age (range from 34 to 68 years), diabetes duration (range from 3 to 12 years), BMI (range from 20 to 30 kg/m2), HbA1c [ range from 7.0 % (53 mmol/mol) to 10 % (86 mmol/mol) ]. Through the detecting, we excluded 6 patients (4 were in A1 stage, 2 was in A2 stage) because of DR. Finally, 48 patients (26 males, 22 females) completed the study.
Who may be able to join
- The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association;
- No smoking history, pulmonary disease nor pulmonary infection within a fortnight;
- Did not have hepatopathy, nephropathy, and gastrointestinal disease; and
- Likely to have good compliance and able to visit our hospital for periodic assessments.
Who cannot join
- T1DM, gestation and lactation;
- Renal inadequacy, a serum creatinine >132 µmol/L (male), or a serum creatinine >123 µmol/L (female);
- hypohepatia, the liver enzyme was two times higher than normal;
- Intensive care with insulin treatment;
- The patients combinated with DR and hypertension (antihypertensive drugs were used);
- Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or introacular surgery;
- New York Heart Association class III or IV heart failure, a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months; 8) Cholesterol-lowering drugs can not control the blood-fat (TC > 250 mg/dl, HDL-C < 30 mg/dL, LDL-C > 170 mg/dl, TG > 200 mg/dl) adequately; and
- 9) Use of systemically injected glucocorticoids within 3 months prior to our study.
About this study
Official title: Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters of Retrobulbar Blood Vessels in Patients With Type 2 Diabetes
Objective: The main target of this study was to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients with type 2 diabetes (T2DM) without diabetic retinopathy (DR).
Method: T2DM patients without DR were choose to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c, FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler imaging (CDI).
Read the detailed description
Pulmonary function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the retrobulbar circulation (PSV, EDV, RI);retrobulbar blood vessels (CRA, PCA, and OA);blood-fat(TC, HDL-C, LDL-C, and TG).
Pulmonary function was measured by spirometer which was provided by Jaska Corporation in Japan, model number: HI-101; The CDI recordings were taken using a Powervision SSA-380A (Toshiba, Japan) using a 7-MHz transducer.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- spirometer;Intraocular pressure;Color doppler imaging
- 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.
spirometer;Intraocular pressure;Color doppler imagingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The pulmonary function (using spirometer)of three categories of patients, based on HbA1c levels, were compared
pulmonary function parameters include: VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%;HbA1c levels: ≥ 8.0, < 8.0 and > 7.0, ≤ 7.0
Measured: one week
The circulatory parameters (using CDI)of retrobulbar blood vessels of three categories of patients, based on HbA1c levels, were compared
retrobulbar blood vessels include CRA, PCA, and OA; circulatory parameters include PSV, EDV, and RI; HbA1c levels: ≥ 8.0, < 8.0 and > 7.0, ≤ 7.0
Measured: one week
The correlation between the pulmonary function parameters and the retrobulbar circulation parameters in 48 T2DM patients
Measured: one week
Secondary outcomes (1)
HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients
blood-fat include TC, HDL-C, LDL-C, and TG
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 posted17 May 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionApr 2016
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fourth People's Hospital of Shenyang
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-song Kuang, Fourth People's Hospital of Shenyang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774733
- Sponsor's protocol ID
- F11-262-9-25
- Acronym
- CPCT2DM
- Status last verified
- May 2016
- First submitted
- 7 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
Publications
Tai H, Wang MY, Zhao YP, Li LB, Jiang XL, Dong Z, Lv XN, Liu J, Dong QY, Liu XG, Kuang JS. Pulmonary Function and Retrobulbar Hemodynamics in Subjects With Type 2 Diabetes Mellitus. Respir Care. 2017 May;62(5):602-614. doi: 10.4187/respcare.05129. Epub 2017 Feb 28.
PubMed 28246307
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters of Retrobulbar Blood Vessels in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02774733
- Acronym / sponsor ID
- CPCT2DM / F11-262-9-25
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fourth People's Hospital of ShenyangUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
Objective: The main target of this study was to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients with type 2 diabetes (T2DM) without diabetic retinopathy (DR).
Method: T2DM patients without DR were choose to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c, FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler imaging (CDI).
Detailed description
Pulmonary function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the retrobulbar circulation (PSV, EDV, RI);retrobulbar blood vessels (CRA, PCA, and OA);blood-fat(TC, HDL-C, LDL-C, and TG).
Pulmonary function was measured by spirometer which was provided by Jaska Corporation in Japan, model number: HI-101; The CDI recordings were taken using a Powervision SSA-380A (Toshiba, Japan) using a 7-MHz transducer.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 34 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators selected 60 patients (34 males, 26 females) with T2DM from the the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 48 patients (26 males, 22 females) can be researched in our study. All patients were provided a diet and exercise program by professional nutritionists. The race ratio (all were Chinese Hans), age (range from 34 to 68 years), diabetes duration (range from 3 to 12 years), BMI (range from 20 to 30 kg/m2), HbA1c [ range from 7.0 % (53 mmol/mol) to 10 % (86 mmol/mol) ]. Through the detecting, we excluded 6 patients (4 were in A1 stage, 2 was in A2 stage) because of DR. Finally, 48 patients (26 males, 22 females) completed the study.
Key inclusion criteria (4 listed)
- The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association;
- No smoking history, pulmonary disease nor pulmonary infection within a fortnight;
- Did not have hepatopathy, nephropathy, and gastrointestinal disease; and
- Likely to have good compliance and able to visit our hospital for periodic assessments.
Key exclusion criteria (8 listed)
- T1DM, gestation and lactation;
- Renal inadequacy, a serum creatinine >132 µmol/L (male), or a serum creatinine >123 µmol/L (female);
- hypohepatia, the liver enzyme was two times higher than normal;
- Intensive care with insulin treatment;
- The patients combinated with DR and hypertension (antihypertensive drugs were used);
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 |
|---|---|---|
| spirometer;Intraocular pressure;Color doppler imaging | Device | – |
Primary outcome
The pulmonary function (using spirometer)of three categories of patients, based on HbA1c levels, were compared
Time frame: one week
pulmonary function parameters include: VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%;HbA1c levels: ≥ 8.0, < 8.0 and > 7.0, ≤ 7.0
The circulatory parameters (using CDI)of retrobulbar blood vessels of three categories of patients, based on HbA1c levels, were compared
Time frame: one week
retrobulbar blood vessels include CRA, PCA, and OA; circulatory parameters include PSV, EDV, and RI; HbA1c levels: ≥ 8.0, < 8.0 and > 7.0, ≤ 7.0
The correlation between the pulmonary function parameters and the retrobulbar circulation parameters in 48 T2DM patients
Time frame: one week
1 secondary outcome
HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 28246307Tai H, Wang MY, Zhao YP, Li LB, Jiang XL, Dong Z, Lv XN, Liu J, Dong QY, Liu XG, Kuang JS. Pulmonary Function and Retrobulbar Hemodynamics in Subjects With Type 2 Diabetes Mellitus. Respir Care. 2017 May;62(5):602-614. doi: 10.4187/respcare.05129. Epub 2017 Feb 28.
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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 Fourth People's Hospital of Shenyang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 17 May 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The pulmonary function (using spirometer)of three categories of patients, based on HbA1c levels, were compared (time frame: one week). The study lists 3 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 NCT02774733, 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 17 May 2016.