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

UMIN ID: UMIN000027029

Registered date:17/04/2017

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Women with gestational diabetes mellitus(GDM)
• Date of first enrollment: 2017/05/08
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

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 Patients diagnosed with diabetes will be withdrawn.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 Patients diagnosed with diabetes will be withdrawn.

Outcome(s)

• Primary Outcome: 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
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Female
• 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

• Primary Sponsor: National Center for Child Health and Development, Tokyo, Japan
• Source(s) of Monetary Support: AMED