Research of Intensive Metabolic Intervention Before Pregnancy in PCOS
- Conditions
- PCOSImpaired Glucose Tolerance
- Interventions
- Registration Number
- NCT03383068
- Lead Sponsor
- RenJi Hospital
- Brief Summary
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
- Detailed Description
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 160
- PCOS women at Childbearing Age
- PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.
- Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
- History of current or past pregnancy
- Hormonal contraceptive or metformin use within 3 months of enrollment
- Nonclassical congenital adrenal hyperplasia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orlistat Orlistat metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months Exenatide Exenatide metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months acarbose Acarbose 100 MG metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months control Metformin metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
- Primary Outcome Measures
Name Time Method Improvement of pregnant rate after intensive metabolic intervention up to 24 weeks To compare the pregnant rate of four groups after treatment
- Secondary Outcome Measures
Name Time Method Improvement of obsorbtion rate after intensive metabolic intervention up to 24 weeks To compare the obsorbtion rate of four groups after treatment
Improvement of stillborn foetus rate after intensive metabolic intervention up to 24 weeks To compare the stillborn foetus rate of four groups after treatment
Improvement of hyperandrogenism up to 24 weeks To compare the free androgen index of three groups after treatment
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation up to 24 weeks To compare the intravenous blood glucose of three groups after treatment
Improvement of triglyceride up to 24 weeks To compare the circulating triglyceride of three groups after treatment
Trial Locations
- Locations (1)
Renji Hospital Department of Endocrinology and Metabolism
🇨🇳Shanghai, Shanghai, China