UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of the mechanism of coronary plaque development: Observation of circadian rhythm in blood glucose using CGM (continuous glucose monitoring)
Title of the study (Brief title)	Elucidation of the mechanism of coronary plaque development: Observation of circadian rhythm in blood glucose using CGM (continuous glucose monitoring)
Region	Japan

Condition
Condition	coronary artery disease patients without DM(diabetes mellitus)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the plaque characteristics, circadian rhythm of blood glucose and sympathetic activation in the coronary artery disease patients without DM.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	circadian rhythm in the blood glucose using CGM plaque characteristics in the optical coherence tomography (OCT)
Key secondary outcomes	Sympathetic activity in the Holter electrocardiogram

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	coronary artery disease patients without diabetes mellitus
Key exclusion criteria	diabetes mellitus patients
Target sample size	100

Research contact person
Name of lead principal investigator	Wataru Shimizu
Organization	Nippon Medical School Department of Medicine
Division name	Division of Cardiology
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL	03-3822-2131
Email	ykubota@nms.ac.jp

Public contact
Name of contact person	Yoshiaki Kubota
Organization	Nippon Medical School Department of Medicine
Division name	Division of Cardiology
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL	03-3822-2131
Homepage URL
Email	ykubota@nms.ac.jp

Sponsor
Institute	Nippon Medical School Department of Medicine Division of Cardiology
Institute
Department

Funding Source
Organization	Nippon Medical School Department of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2015 Year 07 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design:prospective Evaluate item:circadian rhythm in the blood glucose using CGM, plaque characteristics in the optical coherence tomography (OCT)

Management information
Registered date	2015 Year 07 Month 06 Day
Last modified on	2018 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021078