UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018459 |
|---|---|
| Receipt number | 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 11:19:25 |
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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
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
nsatoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
