UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015663 |
|---|---|
| Receipt number | R000017881 |
| Scientific Title | Verification of the effect of exercise to pregnant women with glucose intolerance |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2018/07/10 10:23:23 |
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Basic information
Public title
Verification of the effect of exercise to pregnant women with glucose intolerance
Acronym
Verification of the effect of exercise to pregnant women with glucose intolerance
Scientific Title
Verification of the effect of exercise to pregnant women with glucose intolerance
Scientific Title:Acronym
Verification of the effect of exercise to pregnant women with glucose intolerance
Region
| Japan |
Condition
Condition
pregnant women with glucose intolerance
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pregnant women with glucose intolerance are directed about daily steps. We investigate the change of blood sugar level for them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
blood sugar level
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant women with glucose intolerance
Key exclusion criteria
under 20 years old, pregnant women with fetal disorder, pregnant women who cannot reply to a questionnaire, pregnant women who cannot understand Japanese
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Suganuma |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513912
suganuma.nobuhiko.4s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Hayashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513912
Homepage URL
884ayako@gmail.com
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/jog.13698
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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2014 | Year | 11 | Month | 11 | Day |
Last modified on
| 2018 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017881
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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