NCT Number: NCT02774733
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
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).
Looking for future studies?
Notify MeKey information
Conditions
Age range
34 year–68 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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
Time frame: one week
blood-fat include TC, HDL-C, LDL-C, and TG
Sponsors and collaborators
Lead sponsor
Fourth People's Hospital of Shenyang
Other
Registry information
Official study title
Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters of Retrobulbar Blood Vessels in Patients With Type 2 Diabetes
Acronym: CPCT2DM
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- May 17, 2016
- Registry last updated
- May 17, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Efficacy of Educational Nutrition and Exercise on the Regulation of Appetite Through Exosomes in Type 2 Diabetics
NCT05259449
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cadiz, Spain
View Trial DetailsUric Acid Lowering Trial in Youth Onset T2D
NCT03899883
Diabetes, Diabetes Complications
Aurora, Colorado, United States
View Trial DetailsMitochondrial Metabolism and Oxidative Stress in Function of the Physical Exercise and Nutritional Counseling in T2DM
NCT07251504
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cádiz, Spain
View Trial DetailsEffect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus
NCT00445627
Body Weight, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial Details