UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029438 |
|---|---|
| Receipt number | R000033635 |
| Scientific Title | A follow-up study to evaluate the risk of later development of type 1 diabetes in the gestational diabetes mellitus patients with presence of GAD antibody in Japan |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2020/10/08 08:54:38 |
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Basic information
Public title
A follow-up study to evaluate the risk of later development of type 1 diabetes in the gestational diabetes mellitus patients with presence of GAD antibody in Japan
Acronym
Positive GAD-GDM in Japan
Scientific Title
A follow-up study to evaluate the risk of later development of type 1 diabetes in the gestational diabetes mellitus patients with presence of GAD antibody in Japan
Scientific Title:Acronym
Positive GAD-GDM in Japan
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 investigate the risk of later development of type 1 diabetes and changes in glucose metabolism in the gestational diabetes mellitus patients with presence of GAD antibodies in Japan
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between ability of insulin secretion and development of type 1 diabetes
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development of type 1 diabetes
Key secondary outcomes
Antibody titer of GAD
Glucose tolerance
Ability of insulin secretion
Insulin sensitivity
HbA1c
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
gestational diabetes mellitus patients with presence of GAD antibodies in Japan
Key exclusion criteria
Overt DM in pregnancy
type 1 diabetes in pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishikawa |
Organization
National Hospital Organization, Kumamoto Medial Center
Division name
Department of Diabetes and Endocrinology
Zip code
8600008
Address
Ninomaru 1-5, Chuo-ku, Kumamoto, 860-0008, Japan
TEL
096-353-6501
takeshi129@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishikawa |
Organization
National Hospital Organization, Kumamoto Medial Center
Division name
Department of Diabetes and Endocrinology
Zip code
8600008
Address
Ninomaru 1-5, Chuo-ku, Kumamoto, 860-0008, Japan
TEL
096-353-6501
Homepage URL
takeshi129@gmail.com
Sponsor or person
Institute
National Hospital Organization, Kumamoto Medial Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Kumamoto Medial Center
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
National Hospital Organization, Kumamoto Medial Center
Address
Ninomaru 1-5, Chuo-ku, Kumamoto, 860-0008, Japan
Tel
096-353-6501
takahashi.kazue.ck@mail.hosp.go.jp
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
| 2018 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After delivery, examinations related to glucose tolerance are performed once a year.
The time of follow-up for women with presence of GAD antibody is 5 years.
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033635
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
