UMIN-CTR Clinical Trial

Basic information
Public title	The assessment of endothelial function: significance in the diagnosis and management of dyslipidemia (an observational study).
Acronym	endothelial function in dyslipidemia
Scientific Title	The assessment of endothelial function: significance in the diagnosis and management of dyslipidemia (an observational study).
Scientific Title:Acronym	endothelial function in dyslipidemia
Region	Japan

Condition
Condition	Dyslipidemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To assess the endothelial function by flow-mediated dilatation (FMD) and nitroglycerine-mediated dilatation (NMD) in patients with dyslipidemia.
Basic objectives2	Others
Basic objectives -Others	To assess the significance of FMD/NMD in the diagnosis and management of dyslipidemia.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1) endothelium-dependent vasodilatation (FMD) 2) endothelium-independent vasodilatation (NMD)
Key secondary outcomes	1) surrogate marker of atherosclerosis (intima-media thickness (IMT), pulse wave velocity (PWV), cardio-ankle vascular index (CAVI), ankle brachial index (ABI)). 2) lipid profiles (total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, remnant-like particle-cholesterol (RLP-C), Lp(a), fatty acids, apoA1, apoB, apoC2, apoC3, apoE). 3) safety of nitroglycerine in NMD test.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) familial hypercholesterolemia 2) hyperlipoproteinemia (Fredrickson types 4 and 5) 3) other types of primary dyslipidemia 4) diabetic dyslipidemia
Key exclusion criteria	1) patients with peripheral artery diseases of upper limbs 2) patients who are considered inappropriate as subjects for FMD and NMD tests
Target sample size	180

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroaki Okazaki
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Diabetes and Metabolic Diseases
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	+81-(0)3-3815-5411
Email	hokazaki-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroaki Okazaki
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Diabetes and Metabolic Diseases
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	+81-(0)3-3815-5411
Homepage URL
Email	hokazaki-tky@umin.ac.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
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IRB Contact (For public release)
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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	2015 Year 04 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Results Delayed
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Baseline Characteristics
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Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date	2014 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To assess the significance of FMD/NMD in the diagnosis and management of dyslipidemia.

Management information
Registered date	2015 Year 04 Month 15 Day
Last modified on	2019 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019878