UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	dyslipidemia
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
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	Medicine
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	70 years-old >=
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

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuaki Dohi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Cardio-Renal Medicine and Hypertension
Zip code
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Cardio-Renal Medicine and Hypertension
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 08 Month 27 Day
Last modified on	2010 Year 11 Month 02 Day

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
Registered date	File name

Research case data
Registered date	File name

Contact us.