UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008846 |
|---|---|
| Receipt number | R000010370 |
| Scientific Title | Effect of dietary protein restriction on the progression of chronic kidney disease in patients with type 2 diabetes, a randomized controlled pilot study. |
| Date of disclosure of the study information | 2012/09/04 |
| Last modified on | 2016/03/04 10:31:51 |
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Basic information
Public title
Effect of dietary protein restriction on the progression of chronic kidney disease in patients with type 2 diabetes, a randomized controlled pilot study.
Acronym
PROP-CKD study
Scientific Title
Effect of dietary protein restriction on the progression of chronic kidney disease in patients with type 2 diabetes, a randomized controlled pilot study.
Scientific Title:Acronym
PROP-CKD study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease in patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of dietary protein restriction on the progression of chronic kidney disease in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of eGFR (estimated Glomerular Filtration Rate)
Key secondary outcomes
Body weight, Body mass index, Blood pressure, HbA1c, Observance rate, Food behavior modification, QOL at before and after dietary protein restriction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Intensive nutrition education group.
We perform nutrition education once in two months after education hospitalization, and follow up until one year later.
Interventions/Control_2
Control group.
We perform nutrition education once in six months after education hospitalization, and follow up until one year later.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with type 2 diabetes.
2)Patients with non-dialysis-dependent chronic kidney disease ( eGFR < 60 ml/min/1.73m2 ).
3)Patients with the medical inspection of the chief physician.
4)Patients with the consent of the chief physician for this study.
5)Patients is willing to participate for this study.
6)Patients who agree to the purpose and contents of this study.
7)Patients who voluntary consent document was obtained.
8)Patients with education hospitalization.
9)Patients who perform dietary protein restriction for the first time.
Key exclusion criteria
1)Patients consent was not obtained for this study.
2)Patients who judged that the chief physician were not suitable for this study.
3)Patients who can not understand the contents of this study.
4)Patients having serious complications.
5)Patients having respiratory disease, and circulatory system disease.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinobu Satoh |
Organization
Chigasaki Minicipal Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-15-1 Honson, Chigasaki-shi, Kanagawa, JAPAN
TEL
0467-52-1111
ushigome-k@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinobu Satoh |
Organization
Chigasaki Minicipal Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-15-1 Honson, Chigasaki-shi, Kanagawa, JAPAN
TEL
0467-52-1111
Homepage URL
ushigome-k@kuhs.ac.jp
Sponsor or person
Institute
Chigasaki Minicipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
茅ヶ崎市立病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 04 | 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
| 2012 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 20 | 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
| 2012 | Year | 09 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010370
| 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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