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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010573
Receipt No. R000012366
Scientific Title Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Date of disclosure of the study information 2013/04/23
Last modified on 2016/05/31

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Basic information
Public title Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Acronym Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Scientific Title Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Scientific Title:Acronym Study for investigating the secretion of incretin and glucagon in pregnant women with gestational diabetes mellitus
Region
Japan

Condition
Condition Gestational Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the secretion of GLP-1, GIP, and glucagon in pregnant women with gestational diabetes mellitus
Basic objectives2 Others
Basic objectives -Others To assess the secretion of endogenic hormone in vivo
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The secretion of incretin, and glucagon during 75g oral glucose tolerance test
Key secondary outcomes Identification of risk factor of gestational diabetes mellitus that needs insulin therapy or not

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
16 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria The pregnant woman with 24 to 30 weeks of gestational age who are scheduled 75g oral glucose tolerance test
Key exclusion criteria The woman who has diabetes before pregnancy; has overt diabetes during pregnancy; uses the drug affecting blood glucose; has GAD65 antibody
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Morita
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higasi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL 053-435-2263
Email moritahr@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Hashimoto
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higasi-ku Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL 053-435-2263
Homepage URL
Email hamaihashimototakuya@yahoo.co.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 浜松医科大学医学部附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 23 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 23 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To assess the secretion of incretin, glucagon, and somatostatin during 75g oral glucose tolerance test in pregnant women with gestational diabetes mellitus

Management information
Registered date
2013 Year 04 Month 23 Day
Last modified on
2016 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012366

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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