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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012234
Receipt No. R000014307
Scientific Title The PRebiotics Effect on Endotoxinemia in type 2 Diabetes
Date of disclosure of the study information 2013/11/11
Last modified on 2013/11/07

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Basic information
Public title The PRebiotics Effect on Endotoxinemia in type 2 Diabetes
Acronym PREED
Scientific Title The PRebiotics Effect on Endotoxinemia in type 2 Diabetes
Scientific Title:Acronym PREED
Region
Japan

Condition
Condition type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of GOS on endotoxinemia in type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum LBP,LPS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 GOS
Interventions/Control_2 placebo
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
65 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetes treated over 3 months
Key exclusion criteria patients prescribed alpha-GI and antibiotics
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumiko Hamano
Organization Kantoh Rosai Hospital
Division name diabetes and endoclinology
Zip code
Address Kanagawa-prefecture Kawasaki-city Nakahara-ku Kizukisumiyoshicho 1-1
TEL 044-411-3131
Email teamdm@kantoh.rofuku.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kato Hiroko
Organization Kantoh Rosai Hospital
Division name diabetes and endoclinology
Zip code
Address Kanagawa-prefecture Kawasaki-city Nakahara-ku Kizukisumiyoshicho 1-1
TEL 044-411-3131
Homepage URL
Email teamdm@kantoh.rofuku.go.jp

Sponsor
Institute Kantoh Rosai Hospital
Institute
Department

Funding Source
Organization Yakult
Organization
Division
Category of Funding Organization Profit organization
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 関東労災病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 11 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
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 Preinitiation
Date of protocol fixation
2013 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 07 Day
Last modified on
2013 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014307

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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