UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027029
Receipt number 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 13:48:46

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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 Obstetrics 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 or person

Institute

National Center for Child Health and Development, Tokyo, Japan

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030617