UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034547 |
|---|---|
| Receipt number | R000039084 |
| Scientific Title | Glucose tolerance evaluation by continuous glucose monitoring (CGM) after gestational diabetes |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2020/10/28 13:49:45 |
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Basic information
Public title
Glucose tolerance evaluation by continuous glucose monitoring (CGM) after gestational diabetes
Acronym
Glucose tolerance evaluation by CGM after GDM
Scientific Title
Glucose tolerance evaluation by continuous glucose monitoring (CGM) after gestational diabetes
Scientific Title:Acronym
Glucose tolerance evaluation by CGM after GDM
Region
| Japan |
Condition
Condition
Gestational Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate glucose tolerance by continuous blood glucose monitoring after birth of a gestational diabetic patient and compare it with the data of postpartum women who did not develop gestational diabetes. And to investigate the possibility of predicting onset of impaired glucose tolerance before obvious and residual of impaired glucose tolerance.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in blood glucose fluctuation between 7 and 14 days in GDM group and non-GDM group.
Key secondary outcomes
Evaluate the difference such as HbA1c, glycoalbumin and Continuous overlapping net Glycemic Action (CONGA), SD, Mean, Max, Min and J-index in CGM data, between GDM group and non-GDM group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Postpartum patients of Gestational diabetes attach CGM between 7 to 14 days.The patient takes a test meal one day during wearing.
Interventions/Control_2
Healthy postpartum women are control group and attach CGM between 7 to 14 days.They takes a test meal one day during wearing.
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
GDM group:Women who gave birth at University Hospital Kyoto Prefectural University of Medicine or Adachi Hospital.And those who have been diagnosed with gestational diabetes during pregnancy and are over 6 months and within 3 years after birth and after resuming menstruation,who are not pregnant or lactating.
Patients who gave birth at Adachi Hospital are introducted to University Hospital Kyoto Prefectural University of Medicine when after birth examination.
non-GDM group:Women who did not diagnosed gestational diabetes during pregnancy and are over 6 months and within 3 years after birth and after resuming menstruation, who are not pregnant or lactating. We do not limit hospitals they gave birth.
Key exclusion criteria
We exclude patients who have been diagnosed as borderline type diabetes or diabetes type after childbirth and obvious diabetes mellitus during pregnancy and pregnancy with diabetes mellitus.
Patients who the doctor judged inappropriate for participation in the trial, patients who declared non-acceptance of participation are excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Division name
Department of Endocrinology and Metabolism
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
075-252-5505
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Kitae |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Division name
Department of Endocrinology and Metabolism
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL
075-252-5506
Homepage URL
kitaeaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
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
the institutional review board of the Hospital of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
Tel
075-251-5337
kpu@bvits.com
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
京都府立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 31 | 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
| 2018 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039084
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