UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014404 |
|---|---|
| Receipt number | R000016757 |
| Scientific Title | Investigation of atherosclerotic formation mechanisms associating diurnal variation of blood glucose in patients with lifestyle-related disease |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/06/27 17:13:02 |
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Basic information
Public title
Investigation of atherosclerotic formation mechanisms associating diurnal variation of blood glucose in patients with lifestyle-related disease
Acronym
Investigation of atherosclerotic formation mechanisms associating diurnal variation of blood glucose in patients with lifestyle-related disease
Scientific Title
Investigation of atherosclerotic formation mechanisms associating diurnal variation of blood glucose in patients with lifestyle-related disease
Scientific Title:Acronym
Investigation of atherosclerotic formation mechanisms associating diurnal variation of blood glucose in patients with lifestyle-related disease
Region
| Japan |
Condition
Condition
lifestyle-related disease and healthy volunteer
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates which parts of diurnal variation of blood glucose might be associated with atherosclerotic formation in patients with lifestyle-related disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The standard deviation of the magnitude of diurnal blood glucose variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
None
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
Patients with ifestyle-related disease and healthy volunteers
Key exclusion criteria
Malignancy, liver disease, and renal failure
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumino Hiroyuki |
Organization
Gunma University Hospital
Division name
Clinical Laboratory Center
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8576
suminoh@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumino Hiroyuki |
Organization
Gunma University Hospital
Division name
Clinical Laboratory Center
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8576
Homepage URL
suminoh@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
Organization
Division
Category of Funding Organization
Other
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
群馬大学医学部附属病院(群馬県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2014 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016757
