UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024880
Receipt No. R000028632
Scientific Title Research to develop the program for prevention aggravation of diabetic nephropathy
Date of disclosure of the study information 2016/11/18
Last modified on 2018/06/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Research to develop the program for prevention aggravation of diabetic nephropathy
Acronym The program for prevention aggravation
of diabetic nephropathy
Scientific Title Research to develop the program for prevention aggravation of diabetic nephropathy
Scientific Title:Acronym The program for prevention aggravation
of diabetic nephropathy
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of lifestyle intervention program for prevention aggravation of diabetic nephropathy and to explore the effects of the programs
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes medical examination rate, HbA1c, serum Cr,
stage of diabetic nephropathy,
rate of dyalisys
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Encourage patients with diabetic nephropathy to take medical treatment
Interventions/Control_2 Perform health guidance for patients with diabetic nephropathy to prevent aggravation diabetic nephropathy
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diabetes,Diabetic nephropathy
Key exclusion criteria Dementia,
patients with severe diseases such as cancers or cardiovascular diseases, in case of prohibition to join the program by doctors
Target sample size 880

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyo Tsushita
Organization Aichi Health Promotion Public Interest Foundation
Division name Comprehensive Health Science Center
Zip code
Address Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL 0562-82-0211
Email k-tsushita@grp.ahv.pref.aichi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Muramoto
Organization Aichi Health Promotion Public Interest Foundation
Division name Comprehensive Health Science Center
Zip code
Address Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL 0562-82-0211
Homepage URL
Email a-muramoto@grp.ahv.pref.aichi.jp

Sponsor
Institute Aichi Health Promotion Public Interest Foundation
Institute
Department

Funding Source
Organization Ministry of Health,Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 11 Month 18 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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 17 Day
Last modified on
2018 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.