UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008749 |
|---|---|
| Receipt number | R000010117 |
| Scientific Title | Relation of proinsulin concentration and disposition index in diabetic patients |
| Date of disclosure of the study information | 2012/08/22 |
| Last modified on | 2017/08/27 06:46:46 |
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Basic information
Public title
Relation of proinsulin concentration and disposition index in diabetic patients
Acronym
Relation of proinsulin concentration and disposition index in diabetic patients
Scientific Title
Relation of proinsulin concentration and disposition index in diabetic patients
Scientific Title:Acronym
Relation of proinsulin concentration and disposition index in diabetic patients
Region
| Japan |
Condition
Condition
nomarl glucose tolerant, impaired glucose tolerant, and diabetic subjects
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ingestigate relationship between disposition index and basal plasma concentration of insulin, C-peptide, proinsulin, glucagon and adiponectin.
Basic objectives2
Others
Basic objectives -Others
NONE
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Existance of any relation between disposition index and measured hormonal and substance levels including any indices obtained from measured values
Key secondary outcomes
not settled
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
those who can visit the hospital with fasting state, and who approved this study.
Key exclusion criteria
those who decline this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Dept. of Endocrinology and Diabetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
049-228-3564
matsudam-ind@umn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Dept. of Endocrinology and Diabetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
0449-228-3564
Homepage URL
matsudam-ind@umin.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University,Dept. of Endocrinology and Diabetes
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University,Dept. of Endocrinology and Diabetes
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
| 2012 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between the disposition index and other variables will be studied.
Management information
Registered date
| 2012 | Year | 08 | Month | 22 | Day |
Last modified on
| 2017 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010117
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
