UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018204 |
|---|---|
| Receipt number | R000021078 |
| Scientific Title | Elucidation of the mechanism of coronary plaque development: Observation of circadian rhythm in blood glucose using CGM (continuous glucose monitoring) |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2018/02/11 16:00:34 |
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Basic information
Public title
Elucidation of the mechanism of coronary plaque development: Observation of circadian rhythm in blood glucose using CGM (continuous glucose monitoring)
Acronym
Elucidation of the mechanism of coronary plaque development: Observation of circadian rhythm in blood glucose using CGM (continuous glucose monitoring)
Scientific Title
Elucidation of the mechanism of coronary plaque development: Observation of circadian rhythm in blood glucose using CGM (continuous glucose monitoring)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Wataru Shimizu |
Organization
Nippon Medical School Department of Medicine
Division name
Division of Cardiology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL
03-3822-2131
ykubota@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kubota |
Organization
Nippon Medical School Department of Medicine
Division name
Division of Cardiology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL
03-3822-2131
Homepage URL
ykubota@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Department of Medicine Division of Cardiology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021078
