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CompletedNCT02774733CPCT2DMUpdated May 17, 2016

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

An observational study in Diabetes Mellitus, Type 2, sponsored by Fourth People's Hospital of Shenyang. Completed. Open to participants aged 34 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Fourth People's Hospital of Shenyang · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
48
Ages
34 Years to 68 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 48 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Fourth People's Hospital of Shenyang is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
34 Years to 68 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Investigators selected 60 patients (34 males, 26 females) with T2DM from the the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 48 patients (26 males, 22 females) can be researched in our study. All patients were provided a diet and exercise program by professional nutritionists. The race ratio (all were Chinese Hans), age (range from 34 to 68 years), diabetes duration (range from 3 to 12 years), BMI (range from 20 to 30 kg/m2), HbA1c [ range from 7.0 % (53 mmol/mol) to 10 % (86 mmol/mol) ]. Through the detecting, we excluded 6 patients (4 were in A1 stage, 2 was in A2 stage) because of DR. Finally, 48 patients (26 males, 22 females) completed the study.

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

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
  1. Use of systemically injected glucocorticoids within 3 months prior to our study.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
48 participants (actual)
Patient registry
No

Interventions

  • Devicespirometer;Intraocular pressure;Color doppler imaging
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one week

  2. 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

    Time frame: one week

  3. The correlation between the pulmonary function parameters and the retrobulbar circulation parameters in 48 T2DM patients

    Time frame: one week

Secondary outcomes

  1. HbA1c, FPG, 2hPG, WC,BMI, DBP, SBP, and blood-fat in 48 T2DM patients

    blood-fat include TC, HDL-C, LDL-C, and TG

    Time frame: one week

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 28246307 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02774733
Lead sponsor
Fourth People's Hospital of Shenyang
Responsible party
Jin-song Kuang (Chief physician, Fourth People's Hospital of Shenyang) — Principal investigator
First posted
May 17, 2016
Start date
Aug 2015
Primary completion
Oct 2015
Completion
Apr 2016
Last update
May 17, 2016
View the source record on ClinicalTrials.gov ↗

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