UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the effect of exercise to pregnant women with glucose intolerance
Title of the study (Brief title)	Verification of the effect of exercise to pregnant women with glucose intolerance
Region	Japan

Condition
Condition	pregnant women with glucose intolerance
Classification by specialty	Obsterics 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	Nobuhiko Suganuma
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Human Health Sciences
Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	0757513912
Email	suganuma.nobuhiko.4s@kyoto-u.ac.jp

Public contact
Name of contact person	Ayako Hayashi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Human Health Sciences
Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	0757513912
Homepage URL
Email	884ayako@gmail.com

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 11 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/jog.13698
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017881