UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057730 |
|---|---|
| Receipt number | R000065970 |
| Scientific Title | Elucidation of the mechanisms of gestational diabetes through analysis of plasma microRNA expression during pregnancy and postpartum |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/04/29 09:31:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Elucidation of the mechanisms of gestational diabetes through analysis of plasma microRNA expression during pregnancy and postpartum
Acronym
Pregnancy and postpartum plasma microRNAs in gestational diabetes
Scientific Title
Elucidation of the mechanisms of gestational diabetes through analysis of plasma microRNA expression during pregnancy and postpartum
Scientific Title:Acronym
Pregnancy and postpartum plasma microRNAs in gestational diabetes
Region
| Japan |
Condition
Condition
Gestational diabetes mellitus
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine plasma microRNA expression during pregnancy and postpartum and explore its association with glucose metabolism and GDM-related factors.
Basic objectives2
Others
Basic objectives -Others
To determine plasma microRNA expression during pregnancy and postpartum and explore its association with glucose metabolism and GDM-related factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood levels of microRNAs
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who are scheduled to undergo or have undergone a 75g glucose tolerance test
Key exclusion criteria
Those who the doctor has determined are not suitable for research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mayuko |
| Middle name | |
| Last name | Soma |
Organization
Hokkaido University of Science
Division name
Pharmacotherapy
Zip code
006-8585
Address
15-4-1, Maeda 7-jo,Teine-ku,Sapporo, Hokkaido, Japan
TEL
0116768729
soma-m@hus.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Soma |
Organization
Hokkaido University of Science
Division name
Pharmacotherapy
Zip code
006-8585
Address
15-4-1, Maeda 7-jo,Teine-ku,Sapporo, Hokkaido, Japan
TEL
0116768729
Homepage URL
soma-m@hus.ac.jp
Sponsor or person
Institute
Hokkaido university of science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committe of Hokkaido University of Science
Address
15-4-1, Maeda 7-jo,Teine-ku,Sapporo, Hokkaido, Japan
Tel
011-688-2241
kenkyu@hus.ac.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
手稲渓仁会病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine plasma microRNA expression during pregnancy and postpartum and explore its association with glucose metabolism and GDM-related factors.
Management information
Registered date
| 2025 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065970
