Unique ID issued by UMIN | UMIN000004116 |
---|---|
Receipt number | R000004886 |
Scientific Title | Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Dyslipidemia |
Date of disclosure of the study information | 2010/09/01 |
Last modified on | 2010/11/02 15:04:43 |
Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Dyslipidemia
SEE-THRU Lipid
Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Dyslipidemia
SEE-THRU Lipid
Japan |
dyslipidemia
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
The endothelium is one of the most important targets of cardiovascular risk factors including hypertension, dyslipidemia, and diabetes mellitus. Endothelial dysfunction is not only the initial step of atherosclerosis, leading to systemic vascular damage, but also a novel predictor of cardiovascular events. Sphingosine 1-phosphate (S1P) is a potent bioactive lipid responsible for vascular cell protection in vitro. The present study was designed to investigate (1) relationship of S1P with endothelial function and cardiovascular risk factors and (2) effects of medical treatments on S1P, endothelial function, and their relationship in patients with dyslipidemia.
Efficacy
Primary endpoint is the change in the plasma S1P concentration and endothelial function from baseline to week 8.
(1) The change in lipid profiles (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) from baseline to week 8.
(2) The change in fasting plasma glucose, C-reactive protein, serotonin, malondialdehyde-modified low-density lipoproteitn (MDA-LDL) from baseline to week 8.
(3) The change in urine albumin excretion from baseline to week 8.
(4) The change in brachial-ankle pulse wave velocity from baseline to week 8.
(5) The change in the number of progenitor cell (CD34+ cell) from baseline to week 8.
(6) The change in the number of endothelial progenitor cells (positive for DiI-acLDLuptake and FITC-lectin binding staining) from baseline to week 8.
(7) The change in brachial blood pressure, estimated central aortic pressure, and heart rate from baseline to week 8.
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
No treatment
2
Treatment
Medicine |
SEE-THRU Lipid is a 8-week, prospective, randomized, open, blinded-endpoint (PROBE) study. After a screening phase for eligibility, baseline data are obtained. Then, patients are assigned to receive rosuvastatin (2.5mg, daily) for 8 weeks. Antidyslipidemic drugs other than rosuvastain are not allowed but other medication, if any at baseline, is continued and not changed throughout the study period.
After a screening phase for eligibility, baseline data are obtained. Then, patients are encouraged to modify life style without receiving antidyslipidemic drug for 8 weeks. Antidyslipidemic drugs are not allowed but other medication, if any at baseline, is continued and not changed throughout the study period.
30 | years-old | <= |
70 | years-old | >= |
Male and Female
Patients with dyslipidema who have not been treated with antidyslipidemic drug.
Exclusion criteria are: history of coronary heart disease, heart failure, or stroke; diabetes mellitus; metabolic syndrome; malignant neoplasm; active inflammatory disease; disorder that requires treatment with statin; pregnant women.
60
1st name | |
Middle name | |
Last name | Yasuaki Dohi |
Nagoya City University Graduate School of Medical Sciences
Cardio-Renal Medicine and Hypertension
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
1st name | |
Middle name | |
Last name |
Nagoya City University Graduate School of Medical Sciences
Cardio-Renal Medicine and Hypertension
Nagoya City University Graduate School of Medical Sciences
none
Self funding
NO
2010 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2010 | Year | 05 | Month | 19 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 08 | Month | 27 | Day |
2010 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004886
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |