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
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT02774733
- Lead Sponsor
- Fourth People's Hospital of Shenyang
- Brief 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).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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
- Use of systemically injected glucocorticoids within 3 months prior to our study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pulmonary function (using spirometer)of three categories of patients, based on HbA1c levels, were compared 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 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 one week
- Secondary Outcome Measures
Name Time Method HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients one week blood-fat include TC, HDL-C, LDL-C, and TG