Skip to main content
Clinical Trials/NCT02774733
NCT02774733
Completed
Not Applicable

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

Fourth People's Hospital of Shenyang0 sites48 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Fourth People's Hospital of Shenyang
Enrollment
48
Primary Endpoint
The pulmonary function (using spirometer)of three categories of patients, based on HbA1c levels, were compared
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
April 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fourth People's Hospital of Shenyang
Responsible Party
Principal Investigator
Principal Investigator

Jin-song Kuang

Chief physician

Fourth People's Hospital of Shenyang

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients(one week)

Similar Trials