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

NCT ID: NCT02774733

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

spirometer;Intraocular pressure;Color doppler imaging

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 34 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fourth People's Hospital of Shenyang

OTHER

Sponsor Role: lead

Responsible Party

Jin-song Kuang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28246307 (View on PubMed)

Other Identifiers

F11-262-9-25

Identifier Type: -

Identifier Source: org_study_id