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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017662
Receipt No. R000020471
Scientific Title Prevention of future development of diabetes in employees at public schools
Date of disclosure of the study information 2015/06/01
Last modified on 2020/04/01

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Basic information
Public title Prevention of future development of diabetes in employees at public schools
Acronym Prevention of the development of diabetes
Scientific Title Prevention of future development of diabetes in employees at public schools
Scientific Title:Acronym Prevention of the development of diabetes
Region
Japan

Condition
Condition IGT
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)determination of predictors for diabetes incidence
2)characterization of insulin secretion in nondiabetic Japanese people
Basic objectives2 Others
Basic objectives -Others same as above
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of diabetes or progression to IGT
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
30 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria employees at public schools who recieved check-ups at Hokuriku Central Hospital since April 2006.
Key exclusion criteria taking medications for diabetes, post gastrectomy state, taking anticancer drugs, taking stroids, or positive for the serum hepatitis markers.
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rie Oka
Organization Hokuriku Central Hospital
Division name Internal Medicine
Zip code
Address Nodera123, Oyabe, 932-8503
TEL 0766-67-1150
Email ririoka@goo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rie Oka
Organization Hokuriku Central Hospital
Division name Internal Medicine
Zip code
Address Nodera123, Oyabe, 932-8503
TEL 0766-67-1150
Homepage URL
Email ririoka@goo.jp

Sponsor
Institute Hokuriku Central Hospital
Institute
Department

Funding Source
Organization the Japan Health Promotion Foundation
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
Address
Tel
Email

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
2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24151911
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2006 Year 03 Month 10 Day
Date of IRB
2017 Year 05 Month 10 Day
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information 1) Characterization of insulin secresion and sensitivity in IFG and IGT.
http://www.ncbi.nlm.nih.gov/pubmed/22068110

2)ALT is an independent predictor for the progression from NGT to IGT.
http://www.ncbi.nlm.nih.gov/pubmed/24151911

3)One-hour plasma glucose as a predictor of the development of Type 2 diabetes in Japanese adults.
https://www.ncbi.nlm.nih.gov/pubmed/26482027

Management information
Registered date
2015 Year 05 Month 25 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020471

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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