UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002627
Receipt number R000003202
Scientific Title Fukuoka Diabetes Registry (FDR)
Date of disclosure of the study information 2009/10/16
Last modified on 2023/10/25 11:00:47

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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@hakujyujikai.or.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@hakujyujikai.or.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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

2008 Year 01 Month 04 Day

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

2023 Year 10 Month 25 Day



Link to view the page

Value
https://center6.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