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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017309
Receipt No. 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 2019/10/31

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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 Sumio
Middle name
Last name Kawata
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 Sumio_Kawata@pref.hyogo.lg.jp

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
Institute Hyogo Prefectural Nishinomiya Hospital
Institute
Department

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 5202
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
2019 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.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


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