UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056485 |
|---|---|
| Receipt number | R000064545 |
| Scientific Title | Ability to identify pregnant women who required insulin treatment during pregnancy using the Matsuda Index, an index of insulin resistance. |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/18 11:53:11 |
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Basic information
Public title
Ability to identify pregnant women who required insulin treatment during pregnancy using the Matsuda Index, an index of insulin resistance.
Acronym
Ability to identify pregnant women who required insulin treatment during pregnancy using the Matsuda Index, an index of insulin resistance.
Scientific Title
Ability to identify pregnant women who required insulin treatment during pregnancy using the Matsuda Index, an index of insulin resistance.
Scientific Title:Acronym
Ability to identify pregnant women who required insulin treatment during pregnancy using the Matsuda Index, an index of insulin resistance.
Region
| Japan |
Condition
Condition
Gestational diabetes mellitus
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to identify pregnant women with GDM who will require insulin administration as a prognosis, using an insulin resistance index in pregnant women with abnormal glucose metabolism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The area under the curve (AUC) analysis of receiver operating characteristic curves was performed to identify normal and pregnant women with GDM using insulin resistance indices.
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
| 31 | years-old | <= |
Age-upper limit
| 38 | years-old | >= |
Gender
Female
Key inclusion criteria
insulin resistance indices in 167 normal and 216 GDM pregnant women
Key exclusion criteria
Pregnant women with missing blood draw data
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ainari |
| Middle name | |
| Last name | Konda |
Organization
Hokkaido University of Science
Division name
Department of Pharmacotherapy
Zip code
0068585
Address
15-4-1,Maeda 7-jo,Teine-ku,Sapporo-shi,Hokkaido
TEL
0116768654
kondaa@hus.ac.jp
Public contact
Name of contact person
| 1st name | Ainari |
| Middle name | |
| Last name | Konda |
Organization
Department of Pharmacotherapy, Faculty of Pharmaceutical Sciences, Hokkaido University of Science
Division name
Department of Pharmacotherapy
Zip code
0068585
Address
15-4-1,Maeda 7-jo,Teine-ku,Sapporo-shi,Hokkaido
TEL
0116768654
Homepage URL
kondaa@hus.ac.jp
Sponsor or person
Institute
Faculty of Pharmaceutical Sciences, Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Faculty of Pharmaceutical Sciences, 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
Faculty of Pharmaceutical Sciences, Hokkaido University of Science
Address
15-4-1,Maeda 7-jo,Teine-ku,Sapporo-shi,Hokkaido
Tel
0116768654
kondaa@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
天使病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f1.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled
383
Results
The AUCs for the ability of the HOMA-IR, QUICKI and Matsuda indices to identify GDM were 0.618, 0.618 and 0.744, respectively, with the Matsuda index being the most significant (p < 0.0001). The optimal cutoff values for the HOMA-IR, QUICKI, and Matsuda indices were 1.72, 0.352, and 3.74, respectively.
Results date posted
| 2024 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
167 normal pregnant women and 216 pregnant women with GDM.
Participant flow
completed.
Adverse events
none.
Outcome measures
HOMA-IR,QUICKI,Matsuda index
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The pathogenesis of gestational diabetes remains unclear.
Management information
Registered date
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064545
