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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029438
Receipt No. 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 2019/04/09

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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 Obsterics 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
Email 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
Email takeshi129@gmail.com

Sponsor
Institute National Hospital Organization, Kumamoto Medial Center
Institute
Department

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
Email 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
Anticipated trial start date
2017 Year 08 Month 14 Day
Last follow-up date
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
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033635

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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