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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002627
Receipt No. R000003202
Scientific Title Fukuoka Diabetes Registry (FDR)
Date of disclosure of the study information 2009/10/16
Last modified on 2019/10/23

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Basic information
Public title Fukuoka Diabetes Registry (FDR)
Acronym Fukuoka Diabetes Registry (FDR)
Scientific Title Fukuoka Diabetes Registry (FDR)
Scientific Title:Acronym Fukuoka Diabetes Registry (FDR)
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To study the current state of management in patients with diabetes mellitus in Fukuoka Prefecture.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Development and progression of diabetic complications, genetic analysis, pathophysiology, enviromental factors
Key secondary outcomes

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 Diabetic patients regularly attending outpatient diabetes clinics
Key exclusion criteria Patients taking immunosuppressants
Patients with active malignant tumors
Patients with uncompensated liver cirrhosis
Patients undergoing hemodialysis or CAPD
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Iwase
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicne and Clinical Science
Zip code 812-8582
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5256
Email iwase@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Iwase
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicne and Clinical Science
Zip code 812-8582
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL 092-642-5256
Homepage URL
Email iwase@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicne and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Hisayama Research Institute for Life-style Related Diseases
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyushu University
Address Maidashi 3-1-1, Higashi-ku, Fukuoka
Tel 092-642-6772
Email ijkkyoryoku@jimu.kyushu-u.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
2009 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.diabetes.med.kyushu-u.ac.jp/fdr/
Number of participants that the trial has enrolled 5131
Results
 
Results date posted
2019 Year 10 Month 23 Day
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
2007 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2025 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will register diabetic patients attending diabetes clinics in Fukuoka Prefecture. We will study the pathophysiology and treatment and perform genetic analysis. Prospective follow-up is scheduled for 5 years.
After the first term of 5 years' follow-up, we will continue the second term follow-up for 10 years

Management information
Registered date
2009 Year 10 Month 14 Day
Last modified on
2019 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003202

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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