UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025535 |
|---|---|
| Receipt number | 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 15:03:05 |
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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
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
h-iuchi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029390
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
