UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030225 |
|---|---|
| Receipt number | R000034526 |
| Scientific Title | The examination of associated factors for diabetic nephropathy and elucidation of preventive methods |
| Date of disclosure of the study information | 2017/12/02 |
| Last modified on | 2020/06/07 00:11:29 |
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Basic information
Public title
The examination of associated factors for diabetic nephropathy and elucidation of preventive methods
Acronym
The examination of diabetic nephropathy and its preventive methods
Scientific Title
The examination of associated factors for diabetic nephropathy and elucidation of preventive methods
Scientific Title:Acronym
The examination of diabetic nephropathy and its preventive methods
Region
| Japan |
Condition
Condition
diabetic nephropathy
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the associated factor for progression of diabetic nephropathy and its preventive methods. Additionally, based on its database, we conduct the prospective study, and not only examine the accuracy of the associated factor for progression of diabetic nephropathy and the usefulness of its preventive methods, but also investigate the effect of diabetic nephropath on other complication of diabetes.
Basic objectives2
Others
Basic objectives -Others
Ohters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the associated factors for progression of diabetic nephropathy
Key secondary outcomes
Investigate the associated factors for non-progression of diabetic nephropathy
Investigate delta-eGFR in each stage of diabetic nephropathy
Investigate the effect of diabetic nephropathy on other complication
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetes patients
Key exclusion criteria
Persons judged inappropriate for this study
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Bunzo Matsuura, Teruki Miyake |
| Middle name | |
| Last name | Bunzo Matsuura, Teruki Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
+81899605308
teruki-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon city, Ehime
TEL
+81899605308
Homepage URL
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee of Ehime University Hospital
Address
Toon Ehime
Tel
+81899605914
cttc@m.ehime-u.ac.jp
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
| 2017 | Year | 12 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to identify the associated factor for progression of diabetic nephropathy and its preventive methods. Additionally, based on its database, we conduct the prospective study, and not only examine the accuracy of the associated factor for progression of diabetic nephropathy and the usefulness of its preventive methods, but also investigate the effect of diabetic nephropath on other complication of diabetes.
Management information
Registered date
| 2017 | Year | 12 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034526
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
