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Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

NCT ID: NCT03383068

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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PCOS Impaired Glucose Tolerance

Keywords

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PCOS imparied glucose tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

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

Group Type OTHER

Metformin

Intervention Type DRUG

metformin effective subjects,act as control group

acarbose

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

Group Type EXPERIMENTAL

Acarbose 100 MG

Intervention Type DRUG

for metformin uneffective subjects, using acarbose for 3 months

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

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

for metformin uneffective subjects, using Exenatide for 3 months

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

Group Type EXPERIMENTAL

Orlistat

Intervention Type DRUG

for metformin uneffective subjects, using Orlistatfor 3 months

Interventions

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Acarbose 100 MG

for metformin uneffective subjects, using acarbose for 3 months

Intervention Type DRUG

Exenatide

for metformin uneffective subjects, using Exenatide for 3 months

Intervention Type DRUG

Orlistat

for metformin uneffective subjects, using Orlistatfor 3 months

Intervention Type DRUG

Metformin

metformin effective subjects,act as control group

Intervention Type DRUG

Other Intervention Names

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Acarbose METF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Tao, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Tao Tao, MD

Role: CONTACT

Phone: 86-13817701776

Email: [email protected]

Facility Contacts

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Wei Liu, MD

Role: primary

Other Identifiers

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[2017]055

Identifier Type: -

Identifier Source: org_study_id