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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012416
Receipt No. R000014534
Scientific Title The efficacy of the probiotics for gestational diabetes patients
Date of disclosure of the study information 2013/12/01
Last modified on 2014/12/02

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Basic information
Public title The efficacy of the probiotics for gestational diabetes patients
Acronym The efficacy of the probiotics for gestational diabetes patients
Scientific Title The efficacy of the probiotics for gestational diabetes patients
Scientific Title:Acronym The efficacy of the probiotics for gestational diabetes patients
Region
Japan

Condition
Condition gestational diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Probiotics is expected for improving glucose tolerance. We conducted this study to investigate the influence of the probiotics in yogult for blood glucose profile of the gestational diabetes mellitus(GDM) patients, their baby and glucose tolerance of GDM patients after labor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of insulin therapy for GDM patients, baby's body weight, the number of the patients after labor who diagnosed prediabetes status or diabetes.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients should take 1 yogult(Onakani GG, Takanashi) under standard diet therapy.
Interventions/Control_2 standard diet therapy
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

Not applicable
Gender Female
Key inclusion criteria patients who diagnosed GDM
Key exclusion criteria patients who are allergic to probiotics
patients who have CKD, severe liver failure,severe infection
patients who are under steroidal therapy
patients who were suffered from severe ketosis in recent six months
Target sample size 40

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

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

Sponsor
Institute Kantoh Rosai Hospital
Institute
Department

Funding Source
Organization Kantoh Rosai Hospital
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
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
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results GDM exhibited significantly reduced GLP-1 response at OGTT 120min compared to NGT.
There were no significant differences of infants' weight, mother's GLP-1 response before and after delivery between RD and LD.
However, infants of LD seemed to be smaller than those of RD, and GLP-1 response of LD seemed to be greater than that of RD.
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
2012 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 08 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 27 Day
Last modified on
2014 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014534

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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