UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042832 |
|---|---|
| Receipt number | R000048874 |
| Scientific Title | Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes. |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2020/12/24 10:52:25 |
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Basic information
Public title
Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Acronym
Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Scientific Title
Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Scientific Title:Acronym
Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Region
| Japan |
Condition
Condition
Gestational diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the risk factors for glucose intolerance in women with GDM.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to investigate the predictive factor during the postpartum period for glucose intolerance in women with GDM at a singles perinatal center in Japan by comparing the various factors between the patients with normal glucose tolerance and glucose intolerance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The risk factors for glucose intolerance in women with GDM during the postpartum period
Key secondary outcomes
1) Patient's basic information: age, pre-pregnancy BMI, and previous pregnancy
2) Gestational history of pregnancy and delivery: 75 g OGTT results, weight gain, number of days in pregnancy, maternal perinatal complications
3) Clinical information on the child: child weight, neonatal complications, and Apgar score
4) Treatment: insulin unit count
5) Postpartum information: postpartum 75gOGTT results
6) Patient's medical record information: Family history of diabetes
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
Patients who were diagnosed with GDM between January 1 2015 and May 31 2020 at Yokohama Medical Center, and who had glucose tolerance test within postpartum period.
Key exclusion criteria
Patients were excluded if they had; no measurement for insulin at the postpartum OGTT, been treated with steroid, or overt diabetes.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Tajima |
Organization
Yokohama Medical Center
Division name
Department of endocrinology & metabolism
Zip code
245-8575
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama
TEL
045-851-2621
tajima.kazuki.jn@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Tajima |
Organization
Yokohama Medical Center
Division name
Department of endocrinology & metabolism
Zip code
245-8575
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama
TEL
045-851-2621
Homepage URL
tajima.kazuki.jn@mail.hosp.go.jp
Sponsor or person
Institute
Yokohama Medical Center
Institute
Department
Personal name
Funding Source
Organization
This research will be funded by the basic research funds of the department to which the principal investigator belongs.
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
Yokohama Medical Center, Clinical Trial Management Office
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama
Tel
045-851-2621
700-kenkyu@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
| 2020 | Year | 12 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study using existing medical record information from routine practice, and no burden or risk is expected to arise from participation in this study. The results of the study may be beneficial for future advances in the management of gestational diabetes mellitus.
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048874
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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