UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020720 |
|---|---|
| Receipt number | R000023899 |
| Scientific Title | Establishment of optimal treatment for vascular endothelial dysfunction in patients with lifestyle-related diseases |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2024/01/30 09:24:00 |
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Basic information
Public title
Establishment of optimal treatment for vascular endothelial dysfunction in patients with lifestyle-related diseases
Acronym
Optimal treatment for vascular endothelial dysfunction
Scientific Title
Establishment of optimal treatment for vascular endothelial dysfunction in patients with lifestyle-related diseases
Scientific Title:Acronym
Optimal treatment for vascular endothelial dysfunction
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine optimal treatment for vascular dysfunction in patients with lifestyle-related diseases
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
vascular endothelial function (FMD)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In addition to diet therapy and exercise therapy, administration of optimal drugs to maintain FMD value larger than or equal 6.0%
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with lifestyle-related diseases recruited from department of endocrinology and metabolism Tokushima University Hospital or department of internal medicine Anan Kyoei Hospital
Key exclusion criteria
Patient on hemodialysis or having problems in the arms
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Aihara |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Community Medicine for Diabetes and Metabolic Disorders
Zip code
Address
3-18-15 Kuramoto-cho Tokushima
TEL
088-633-7120
aihara@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Aihara |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Community Medicine for Diabetes and Metabolic Disorders
Zip code
Address
3-18-15 Kuramoto-cho Tokushima
TEL
088-633-7120
Homepage URL
aihara@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Community Medicine for Diabetes and Metabolic Disorders, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
MEXT (Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2016 | Year | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023899
