UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035266 |
|---|---|
| Receipt number | R000040010 |
| Scientific Title | Intra-day blood pressure fluctuation and vascular complications in type 2 diabetes |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2024/06/19 14:04:34 |
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Basic information
Public title
Intra-day blood pressure fluctuation and vascular complications in type 2 diabetes
Acronym
Intra-day blood pressure fluctuation and vascular complications in type 2 diabetes
Scientific Title
Intra-day blood pressure fluctuation and vascular complications in type 2 diabetes
Scientific Title:Acronym
Intra-day blood pressure fluctuation and vascular complications in type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between intra-day blood pressure and vascular complications in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra-day blood pressure fluctuation
Key secondary outcomes
vascular complications
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are able and willing to give consent.
Key exclusion criteria
Dementia
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Satsuki |
| Middle name | |
| Last name | Kawasaki |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
251-0041
Address
1-5-1 Tsujido-Kandai, Fujisawa, Kanagawa
TEL
0466-35-1177
satsukik@med.email.ne.jp
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Kawasaki |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
251-0041
Address
1-5-1 Tsujido-Kandai, Fujisawa, Kanagawa
TEL
0466-35-1177
Homepage URL
satsukik@med.email.ne.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital, Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Shonan Fujisawa Tokushukai Hospital, Department of Endocrinology and Metabolism
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushukai group EC
Address
1-8-7 Koji-machi, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2018 | Year | 12 | Month | 17 | 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
| 2018 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2018 | Year | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040010
