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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025535
Receipt No. R000029390
Scientific Title The relationship between type 2 diabetes and short-term blood pressure variability
Date of disclosure of the study information 2017/01/07
Last modified on 2019/03/27

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Basic information
Public title The relationship between type 2 diabetes and short-term blood pressure variability
Acronym Jikei Tsuruoka Study (JT study)
Scientific Title The relationship between type 2 diabetes and short-term blood pressure variability
Scientific Title:Acronym Jikei Tsuruoka Study (JT study)
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify increased short-term blood pressure variability in the participants with type 2 diabetes, compared with the participants without diabetes
Basic objectives2 Others
Basic objectives -Others To verify the relationship between baroreflex sensitivity and short-term blood pressure variability in the participants with type 2 diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes coefficient variation for diurnal systolic blood pressure variability
Key secondary outcomes coefficient variation for nocturnal systolic blood pressure variability

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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with type 2 diabetes
2) Healty volunteers or patients without type 2 diabetes
Key exclusion criteria 1) having arrhythmia
2) receiving non-dihydropyridine calcium channel blockers
3) receiving digitalis
4) receiving antipsychotics
5) being diagnosed as impaired glucose tolerance or impaired fasting glucose by 75g OGTT
6) having severe renal dysfunction (serum Cr > 2.5 mg/dl)
7) having severe liver dysfunction (3 X the upper limit of normal)
8) having severe infection, severe trauma, or pre and post operation
9) having diabetic ketosis, diabetic coma, or insulin-dependent diabetes mellitus
10) being pregnant
11) having malignancy
12) being unsuitable for participation in the trial for any reason, according to the investigators
13) having myocardial infarction, heart failure or cerebral infarction within a half year
14) heavy drinker
Target sample size 454

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Iuchi
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email h-iuchi@jikei.ac.jp

Public contact
Name of contact person
1st name Iuchi
Middle name
Last name Hiroyuki
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code 105-8461
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email h-iuchi@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number JP15J11642
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Jikei University School of Medicine
Address 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email rinri@jikei.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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 07 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 07 Day
Date of IRB
2016 Year 12 Month 14 Day
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information The prospective study

Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029390

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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