UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017309
Receipt number R000020070
Scientific Title a prospective cohort sutdy about prognosis in type 2 diabetes patients
Date of disclosure of the study information 2015/05/15
Last modified on 2023/05/10 09:30:32

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Basic information

Public title

a prospective cohort sutdy about prognosis in type 2 diabetes patients

Acronym

Nishinomiya study

Scientific Title

a prospective cohort sutdy about prognosis in type 2 diabetes patients

Scientific Title:Acronym

Nishinomiya study

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We follow up type 2 diabetes patients prospectively and evaluate associataion between type 2 diabetes with or without metabolic syndrome and gastroenterological cancer.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

incidence of gastroenterological cancer

Key secondary outcomes

incidence of cardiovascular disease
progression of diabetic nephropathy


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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Type 2 diabetes patients who see a doctor regularly

Key exclusion criteria

Patient on dialysis
Patient who are judged ineligible by physician

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Kohei
Middle name
Last name Okita

Organization

Hyogo Prefectural Nishinomiya Hospital

Division name

Department of internal medicine

Zip code

662-0918

Address

Rokutanjicho 13-9, Nishinomiya City, Hyogo, Japan

TEL

0798-34-5151

Email

okitakou5@gmail.com


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Yoshikawa

Organization

Hyogo Prefectural Nishinomiya Hospital

Division name

Department of internal medicine

Zip code

662-0918

Address

Rokutanjicho 13-9, Nishinomiya City, Hyogo, Japan

TEL

0798-34-5151

Homepage URL


Email

atsushida2002@yahoo.co.jp


Sponsor or person

Institute

Hyogo Prefectural Nishinomiya Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hyogo Prefectural Nishinomiya Hospital

Address

Rokutanjicho 13-9, Nishinomiya City, Hyogo, Japan

Tel

0798-34-5151

Email

kennishi-chiken@hp.pref.hyogo.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

兵庫県立西宮病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 15 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

5212

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

No longer recruiting

Date of protocol fixation

2012 Year 10 Month 01 Day

Date of IRB

2012 Year 10 Month 16 Day

Anticipated trial start date

2012 Year 10 Month 17 Day

Last follow-up date

2023 Year 10 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We regularly follow up type 2 diabetes patients within the routine care


Management information

Registered date

2015 Year 04 Month 28 Day

Last modified on

2023 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020070


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name