UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029538 |
|---|---|
| Receipt number | R000032853 |
| Scientific Title | Visit-to-Visit Blood Pressure Variability and Geriatric Syndrome in Type 2 Diabetes |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/05/07 08:51:11 |
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Basic information
Public title
Visit-to-Visit Blood Pressure Variability and Geriatric Syndrome in Type 2 Diabetes
Acronym
VIVA G Study
Scientific Title
Visit-to-Visit Blood Pressure Variability and Geriatric Syndrome in Type 2 Diabetes
Scientific Title:Acronym
VIVA G Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association with visit-to-visit blood pressure variability and geriatric syndromes
Basic objectives2
Others
Basic objectives -Others
Among geriatric syndromes, to investigate cognitive function and falls and fractures in particular
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between visit-to-visit blood pressure variability and cognitive function
Key secondary outcomes
The association between visit-to-visit blood pressure variability and falls and fractures
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participant has been visiting the hospital for treatment of type 2 diabetes for at least 12 times in the past three years (at intervals of two weeks or more and 6 months or less) and has blood pressure measured.
Key exclusion criteria
On hemodialysis
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Ichigi |
Organization
Kanazawa Hospital
Division name
Medical Staff
Zip code
236-0021
Address
2-8-3 Deiki, Kanazawa-ku, Yokohama-shi
TEL
045-781-2611
yichigi2000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Yoshino |
Organization
Kanazawa Hospital
Division name
Division of Administration
Zip code
236-0021
Address
2-8-3 Deiki, Kanazawa-ku, Yokohama-shi
TEL
045-781-2611
Homepage URL
hideyuki_yoshino@keisuikai.or.jp
Sponsor or person
Institute
Kanazawa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
YCU Center for Novel and Exploratory Clinical Trials
Address
5th floor, 1-1-1 Fukuura Kanazawa-ku, Yokohama-shi
Tel
045-370-7991
nextjim1@yokohama-cu.ac.jp
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
金沢病院（神奈川県）/Kanazawa Hospital (Kanagawa Prefecture)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Being analyzed
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
