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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002279
Receipt No. R000002788
Scientific Title Study on measurement external injected insulin
Date of disclosure of the study information 2009/08/01
Last modified on 2009/09/30

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Basic information
Public title Study on measurement external injected insulin
Acronym Study on measurement external injected insulin
Scientific Title Study on measurement external injected insulin
Scientific Title:Acronym Study on measurement external injected insulin
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to distinguish external injected insulin from internal secreted insulin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes to detect external injected insulin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 after injecting external insulin, measure insulin concetration with two insulin detecting kit simultaneously
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
24 years-old <=
Age-upper limit
45 years-old >=
Gender Male
Key inclusion criteria normal glucose tolerance
Key exclusion criteria diabetes or IGT
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of medicine
Division name Division of diabetes , Metabolism and Endocrinology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 81-78-382-5861
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Sakaguchi
Organization Kobe University Graduate School of medicine
Division name Division of diabetes , Metabolism and Endocrinology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 81-78-382-5861
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of medicine
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2009 Year 08 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 Completed
Date of protocol fixation
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 31 Day
Last modified on
2009 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002788

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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