UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024880 |
|---|---|
| Receipt number | 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 | 2020/11/07 17:57:01 |
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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 | Kazuyo |
| Middle name | |
| Last name | Tsushita |
Organization
Kagawa Nutrition University
Division name
Graduate Schools of Nutrition Sciences
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakao-city, Saitama, Japan
TEL
049-282-3717
tsushita.kazuyo@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyo |
| Middle name | |
| Last name | Tsushita |
Organization
Kagawa Nutrition University
Division name
Graduate Schools of Nutrition Sciences
Zip code
350-0288
Address
3-9-21, Chiyoda, Sakao-city, Saitama, Japan
TEL
049-282-3717
Homepage URL
http://www.ktsushita.com/cn4/pg3499.html
tsushita.kazuyo@eiyo.ac.jp
Sponsor or person
Institute
Ministry of Health,Labour and Welfare
Institute
Department
Personal name
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
Kagawa Nutrition University
Address
3-9-21, Chiyoda, Sakao-city, Saitama, Japan
Tel
049-282-7331
kenshien@eiyo.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
| 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
7000
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
| 2016 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028632
