Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Impaired Glucose Tolerance; PCOS

Treatments: Drug: Exenatide; Drug: Acarbose 100 MG; Drug: Metformin; Drug: Orlistat

Study type: Interventional

Funder types: Other

Identifiers

NCT03383068

[2017]055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 4 patient groups

control

Other group

Description:

metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance

Treatment:

Drug: Metformin

acarbose

Experimental group

Description:

metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months

Treatment:

Drug: Acarbose 100 MG

Exenatide

Experimental group

Description:

metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months

Treatment:

Drug: Exenatide

Orlistat

Experimental group

Description:

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

Treatment:

Drug: Orlistat