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

Diabetes Mellitus, Type 2 Clinical Trial

— CPCT2DM  

Official title:

Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters of Retrobulbar Blood Vessels in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774733
• Other study ID #: F11-262-9-25
• Status: Completed
• Phase: N/A
• First received: May 7, 2016
• Last updated: May 16, 2016
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Fourth People's Hospital of Shenyang
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Liaoning Province
• Study type: Observational

Clinical 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).

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).

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 34 Years to 68 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• spirometer;Intraocular pressure;Color doppler imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fourth People's Hospital of Shenyang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one week	No
Primary	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	one week	No
Primary	The correlation between the pulmonary function parameters and the retrobulbar circulation parameters in 48 T2DM patients		one week	No
Secondary	HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients	blood-fat include TC, HDL-C, LDL-C, and TG	one week	No