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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030225
Receipt No. 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 2017/12/02

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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
Middle name
Last name Bunzo Matsuura, Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime, Japan
TEL +81899605308
Email teruki-ygc@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon city, Ehime
TEL +81899605308
Homepage URL
Email teruki-ygc@umin.ac.jp

Sponsor
Institute Ehime University
Institute
Department

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
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
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
2017 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034526

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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