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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017145
Receipt No. R000019878
Scientific Title The assessment of endothelial function: significance in the diagnosis and management of dyslipidemia (an observational study).
Date of disclosure of the study information 2015/04/16
Last modified on 2019/05/14

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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
Interventions/Control_2
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
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
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
2015 Year 04 Month 16 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 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/ctr_e/ctr_view.cgi?recptno=R000019878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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