UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017145 |
|---|---|
| Receipt number | 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 13:32:13 |
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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
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
hokazaki-tky@umin.ac.jp
Public contact
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
hokazaki-tky@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019878
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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