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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name