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 UMIN000008846
Receipt No. 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

* 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 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
Email 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
Email ushigome-k@kuhs.ac.jp

Sponsor
Institute Chigasaki Minicipal Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.