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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035266
Receipt No. 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 2018/12/15

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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
Middle name
Last name Satsuki Kawasaki
Organization Shonan Fujisawa Tokushukai Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 1-5-1 Tsujido-Kandai, Fujisawa, Kanagawa
TEL 0466-35-1177
Email satsukik@med.email.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satsuki Kawasaki
Organization Shonan Fujisawa Tokushukai Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 1-5-1 Tsujido-Kandai, Fujisawa, Kanagawa
TEL 0466-35-1177
Homepage URL
Email satsukik@med.email.ne.jp

Sponsor
Institute Shonan Fujisawa Tokushukai Hospital, Department of Endocrinology and Metabolism
Institute
Department

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
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
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
Anticipated trial start date
2018 Year 11 Month 16 Day
Last follow-up date
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
2018 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040010

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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