UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010573 |
|---|---|
| Receipt number | 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 20:15:27 |
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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 | Obstetrics 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
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
hamaihashimototakuya@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012366
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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