Prevention study of diabetes mellitus by intensive lifestyle modification in gestational diabetes mothers:Daisy M Study
- Conditions
- Women with gestational diabetes mellitus(GDM)
- Registration Number
- JPRN-UMIN000027029
- Lead Sponsor
- ational Center for Child Health and Development, Tokyo, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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