UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057929 |
|---|---|
| Receipt number | R000066225 |
| Scientific Title | Glucose Insights in Pregnancy |
| Date of disclosure of the study information | 2025/05/21 |
| Last modified on | 2025/05/21 16:11:21 |
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Basic information
Public title
Studies on blood glucose changes during pregnancy and parturition
Acronym
GIP study
Scientific Title
Glucose Insights in Pregnancy
Scientific Title:Acronym
GIP study
Region
| Japan |
Condition
Condition
Diabetes in pregnancy / Gestational diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Obstetrics and Gynecology |
| Pediatrics | Nursing | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify blood glucose changes during gestation and parturition
Basic objectives2
Others
Basic objectives -Others
To determine blood glucose changes during gestation and parturition in normal glucose-tolerant pregnant women and pregnancies with abnormal glucose metabolism.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean and standard deviation of blood glucose levels for 2 weeks in early, mid, and late pregnancy, parturition, and 3 months postpartum, respectively
Key secondary outcomes
Median, TAR, TIR, TBR, MAGE, and M-values of blood glucose levels for 2 weeks in early, mid, and late pregnancy, parturition, and 3 months postpartum, respectively
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Over 20 years old and under 50 years old
Women who wish to have a baby
Before pregnancy: Normal glucose tolerance or diabetes mellitus
After pregnancy: Pregnant women with normal glucose tolerance, pregnant women with gestational diabetes mellitus, or pregnant women with diabetes mellitus
Key exclusion criteria
Those with other comorbidities (cardiac disease, collagen disease, blood disease, psychiatric disease, etc.)
Those who have exhibited severe symptoms such as contact dermatitis due to adhesive plasters or medical tape in the past
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Furuta |
Organization
Graduate Shcool of Medicine, Kyoto University
Division name
Human Health Sciences
Zip code
606-8397
Address
53 Shogoin Kawahara-cho Sakyo-ku Kyoto-city Kyoto prefecture
TEL
075-751-3946
furuta.marie.8r@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Harashima |
Organization
Graduate Shcool of Medicine, Kyoto University
Division name
Human Health Sciences
Zip code
606-8397
Address
53 Shogoin Kawahara-cho Sakyo-ku Kyoto-city Kyoto prefecture
TEL
075-606-5473
Homepage URL
harashima.shinichi.38m@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin Kawahara-cho Sakyo-ku Kyoto-city Kyoto prefecture
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 21 | 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
300
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will use FGM to identify the following:
1) Blood glucose variability during pregnancy, delivery, and the postpartum period (3 months postpartum*) in normal glucose-tolerant pregnant women
2) Blood glucose variability during pregnancy, delivery, and the postpartum period (3 months postpartum*) in glucose-tolerant pregnant women
3) Glucose threshold, glucose variability, and test timing useful for early GDM diagnosis
4) During delivery Association between blood glucose variability and perinatal prognosis
This study is being conducted in collaboration with 29 medical institutions.
Management information
Registered date
| 2025 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066225
