UMIN-CTR Clinical Trial

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
Last 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
1st 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