Impaired Glucose Tolerance, PCOS
Conditions
Keywords
PCOS, imparied glucose tolerance
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.
Interventions
DRUGAcarbose 100 MG
for metformin uneffective subjects, using acarbose for 3 months
DRUGExenatide
for metformin uneffective subjects, using Exenatide for 3 months
DRUGOrlistat
for metformin uneffective subjects, using Orlistatfor 3 months
DRUGMetformin
metformin effective subjects,act as control group
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of pregnant rate after intensive metabolic intervention | up to 24 weeks | To compare the pregnant rate of four groups after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactTao Tao, MD
Outcome results
None listed