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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000004116 |
Receipt No. | 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 |
Basic information | ||
Public title | Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Dyslipidemia | |
Acronym | SEE-THRU Lipid | |
Scientific Title | Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Dyslipidemia | |
Scientific Title:Acronym | SEE-THRU Lipid | |
Region |
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Condition | ||||
Condition | dyslipidemia | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Primary endpoint is the change in the plasma S1P concentration and endothelial function from baseline to week 8. |
Key secondary outcomes | (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. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -but assessor(s) are blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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. | |
Interventions/Control_2 | 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. | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Patients with dyslipidema who have not been treated with antidyslipidemic drug. | |||
Key exclusion criteria | 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. | |||
Target sample size | 60 |
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Organization | Nagoya City University Graduate School of Medical Sciences | ||||||
Division name | Cardio-Renal Medicine and Hypertension | ||||||
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Address | 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan | ||||||
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Organization | Nagoya City University Graduate School of Medical Sciences | ||||||
Division name | Cardio-Renal Medicine and Hypertension | ||||||
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Institute | Nagoya City University Graduate School of Medical Sciences |
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Funding Source | |
Organization | none |
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Category of Funding Organization | Self funding |
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Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | 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 | |
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Research case data | |
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