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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027029
Receipt No. R000030617
Scientific Title Prevention study of diabetes mellitus by intensive lifestyle modification in gestational diabetes mothers:Daisy M Study
Date of disclosure of the study information 2017/04/17
Last modified on 2017/06/07

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Basic information
Public title Prevention study of diabetes mellitus by intensive lifestyle modification in gestational diabetes mothers:Daisy M Study
Acronym Daisy M Study
Scientific Title Prevention study of diabetes mellitus by intensive lifestyle modification in gestational diabetes mothers:Daisy M Study
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji Hiramatsu
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Obstructs & Gynecology
Zip code
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
1st name
Middle name
Last name Naoko Arat,Maki Kawasaki
Organization National Center for Child Health and Development, Tokyo, Japan
Division name Maternal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 01 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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