UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007354
Receipt number R000008664
Scientific Title Juntendo Type 2 Diabetes and Its Complication Study
Date of disclosure of the study information 2012/02/22
Last modified on 2023/09/01 13:53:07

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Basic information

Public title

Juntendo Type 2 Diabetes and Its Complication Study

Acronym

Juntendo Type 2 Diabetes and Its Complication Study

Scientific Title

Juntendo Type 2 Diabetes and Its Complication Study

Scientific Title:Acronym

Juntendo Type 2 Diabetes and Its Complication Study

Region

Japan


Condition

Condition

Type 2 Diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we conduct biomarker development to be involved in the predictions such as a nephropathy extension / macrovascular disorder, the prognosis.

Basic objectives2

Others

Basic objectives -Others

We follow and, in this study, observe the natural history in patients with diabetes.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Death, macrovascular disorder (cerebral infarction, cerebral hemorrhage, myocardial infarction, angina), microangiopathy (extension of diabetic nephropathy, diabetic retinopathy, dialysis induction)

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

18 years-old <=

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

Type 2 Diabetes

Key exclusion criteria

Type 1 Diabetes

Target sample size

700


Research contact person

Name of lead principal investigator

1st name Tomohito
Middle name
Last name Gohda

Organization

Juntendo University Faculty of Medicine

Division name

Division of Nephrology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

goda@juntendo.ac.jp


Public contact

Name of contact person

1st name Tomohito
Middle name
Last name Gohda

Organization

Juntendo University Faculty of Medicine

Division name

Division of Nephrology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

jinnaika@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University Faculty of medicine

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

kenkyu5858@juntendo.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

2012 Year 02 Month 22 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

235

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

Open public recruiting

Date of protocol fixation

2011 Year 11 Month 01 Day

Date of IRB

2011 Year 10 Month 21 Day

Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We do not give the limits of the treatment to outpatient department attending staff, and it is only follow-up.


Management information

Registered date

2012 Year 02 Month 22 Day

Last modified on

2023 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name