NIPH Clinical Trials Search

UMIN ID: UMIN000027029

Registered date:17/04/2017

Prevention study of diabetes mellitus by intensive lifestyle modification in gestational diabetes mothers:Daisy M Study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedWomen with gestational diabetes mellitus(GDM)
Date of first enrollment2017/05/08
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)<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 Patients diagnosed with diabetes will be withdrawn. <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 Patients diagnosed with diabetes will be withdrawn.


Primary OutcomeRate 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
Secondary Outcome1. 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

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
Include criteria
Exclude 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.

Related Information


public contact
Name Naoko Arat,Maki Kawasaki
Address 10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN Japan
Telephone 03-3416-0181(7011)
Affiliation National Center for Child Health and Development, Tokyo, Japan Maternal Medicine
scientific contact
Name Yuji Hiramatsu
Address 5-1,Shikata,2 chome,Kita,Okayama,700-8558,JAPAN Japan
Telephone 086-235-7320
Affiliation Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Obstructs & Gynecology