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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014404
Receipt No. 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

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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
Email 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
Email suminoh@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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