Women with gestational diabetes mellitus(GDM)
Conditions
Interventions
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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 mo
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 Patients diagnosed with diabetes will be withdrawn.
Sponsors
National Center for Child Health and Development, Tokyo, Japan
Eligibility
Sex/Gender
Female
Inclusion criteria
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);
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Arat,Maki Kawasaki
National Center for Child Health and Development, Tokyo, Japan Maternal Medicine
Outcome results
None listed