UMIN-CTR Clinical Trial

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
Email	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
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	Ethics Committee of Ehime University Hospital
Address	Toon Ehime
Tel	+81899605914
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034526