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

Completed

• 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.

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-07
• Study First Submitted QC: 2016-05-16
• Last Update Submitted: 2016-05-16
• Study First Posted: 2016-05-17
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association;
2. No smoking history, pulmonary disease nor pulmonary infection within a fortnight;
3. Did not have hepatopathy, nephropathy, and gastrointestinal disease; and
4. Likely to have good compliance and able to visit our hospital for periodic assessments.

Exclusion Criteria

1. T1DM, gestation and lactation;
2. Renal inadequacy, a serum creatinine >132 µmol/L (male), or a serum creatinine >123 µmol/L (female);
3. hypohepatia, the liver enzyme was two times higher than normal;
4. Intensive care with insulin treatment;
5. The patients combinated with DR and hypertension (antihypertensive drugs were used);
6. 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;
7. 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.

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