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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018459
Receipt No. R000021378
Scientific Title Japan Diabetes Mellitus Effective Network System Study
Date of disclosure of the study information 2015/07/31
Last modified on 2015/07/30

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Basic information
Public title Japan Diabetes Mellitus Effective Network System Study
Acronym J-DEFENS Study
Scientific Title Japan Diabetes Mellitus Effective Network System Study
Scientific Title:Acronym J-DEFENS Study
Region
Japan

Condition
Condition Type 2 Diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This purpose of this study is as follows:
1) Expansion and standardization of medical cooperation on the research of diabetes.
2) Clarification of the preventive effect of diabetic complications and the economic effect by the medical cooperation on the research of diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)Fasting plasma glucose
2)HbA1c
Key secondary outcomes 1)Severity of diabetic complications
2)The frequency of the examination for diabetic complications
3)The onset and progression of diabetic complications

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetes.
2) Lower age limit: 20 years old
3) Gender: male and female.
4) Outpatients and/or inpatients receiving treatment for lifestyle disease at a hospital.
5) Patients who have provided written informed consent.
Key exclusion criteria 1) Secondary obesity associated with endocrine disorders.
2) Severe liver dysfunction and liver cirrhosis.
3) Severe renal dysfunction (serum creatinine >= 2.0mg/dl).
4) Patients who are pregnant.
5) Subjects judged by the investigator/project lead to be ineligible for other reasons.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Satoh-Asahara
Organization National Hospital Organization, Kyoto Medical Center
Division name Division of Diabetic Research, Clinical Research Institute
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Email nsato@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Satoh-Asahara
Organization National Hospital Organization, Kyoto Medical Center
Division name Division of Diabetic Research, Clinical Research Institute
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Homepage URL
Email nsatoh@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 15Aek0210029h0002
Org. issuing International ID_1 Japan Agency for Medical Research and Development
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都医療センター(京都)、自治医科大学(栃木県)、東京医科歯科大学(東京)、大阪赤十字病院(大阪)、市立岸和田市民病院(大阪)、嶋田病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 11 Month 30 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information prospective cohort study

Management information
Registered date
2015 Year 07 Month 28 Day
Last modified on
2015 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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