UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention study of diabetes mellitus by intensive lifestyle modification in gestational diabetes mothers:Daisy M Study
Title of the study (Brief title)	Daisy M Study
Region	Japan

Condition
Condition	Women with gestational diabetes mellitus(GDM)
Classification by specialty	Endocrinology and Metabolism Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine whether a comprehensive lifestyle intervention(diet,exercise,breastfeeding,education)is more effective than a standard lifestyle intervention alone in preventing type 2 diabetes mellitus in women with GDM.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of progression to glucose abnormalities( including impaired fasting glucose (IFG), or impaired glucose tolerance (IGT), or both (IFG, IGT) or type 2 diabetes mellitus(T2DM) 3 month after postpartum
Key secondary outcomes	1. Rate of progression to T2DM 24 months after postpartum 2.Change in blood glucose and serum insulin levels determined by a 75g oral glucose tolerance test (OGTT) 3.Change in body weight from baseline

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Behavior,custom
Interventions/Control_1	<Comprehensive intensive lifestyle intervention> The comprehensive intensive lifestyle intervention will include the provision of individual advice on diet and exercise wearing pedometer,education and promoting breastfeeding during pregnancy to 3 months postpartum. Also,nutrients advice will be done by mobile application. Patients diagnosed with diabetes will be withdrawn.
Interventions/Control_2	<Standard lifestyle intervention> The standard lifestyle intervention will include the conventional doet and exercize advic during pregnancy to months postpartum. Patients diagnosed with diabetes will be withdrawn.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Women who: (1)diagnosed GDM by 75g oral glucose tolerance test at 24 to 32 weeks of gestation in a singleton pregnancy; (a)prepregnancy BMI>=25 or (b)prepregnancy BMI<25 and the presence of 2 or more the following plasma glucose values are exceeded;fasting>=92mg/dl,1h>=180mg/dl,2h>=153mg/dl (2)can participate in the mobile application(only iOS); (3) can respond to the questionnaire in Japanese; (4) are over 18 years of age(are married if they are under the age of 20 years);
Key exclusion criteria	(1)a history of diabetes(including overt diabetes in pregnancy); (2)cardiovascular disease, respiratory disease, etc. with movement limitation before pregnancy; (3)thyroid function that is not controlled by hyperthyroidism; (4)collagen disease, antiphospholipid antibody syndrome, chronic kidney disease, hypertension; (5)pregnancy-induced hypertension, chronic hypertension hypertension before diagnosed GDM; (6)require hospitalization management with threatened abortion, threatened premature delivery, incompetent cervix, ,cervical length shortening, placenta previa and low-lying placenta; (7)early rupture of membranes; (8)persisting bleeding from the vagina; (9)HIV infection; (10)active tuberculosis ; (11)HTLV-1 carriers ; (12)drug dependence; (13)taking steroids ; (14)diagnosed as a fetus chromosomal abnormality ; (15)diagnosed as cleft lip or palate with multiple fetuses with fetal echo ; (16)intrauterine growth restriction; (17)not considered eligible to participate in this study by the attending doctor due to other reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	Yuji Hiramatsu
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Obstructs & Gynecology
Address	5-1,Shikata,2 chome,Kita,Okayama,700-8558,JAPAN
TEL	086-235-7320
Email	daisymon@ncchd.go.jp

Public contact
Name of contact person	Naoko Arat,Maki Kawasaki
Organization	National Center for Child Health and Development, Tokyo, Japan
Division name	Maternal Medicine
Address	10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN
TEL	03-3416-0181(7011)
Homepage URL
Email	daisymon@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development, Tokyo, Japan
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	国立成育医療研究センター、大阪府立母子総合医療センター、東京医科歯科大学

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 17 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 17 Day
Last modified on	2017 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030617