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Research of Intensive Metabolic Intervention Before Pregnancy in PCOS (PCOS)

Primary Purpose

PCOS, Impaired Glucose Tolerance

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Acarbose 100 MG
Exenatide
Orlistat
Metformin
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring PCOS, imparied glucose tolerance

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Renji Hospital Department of Endocrinology and Metabolism

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

control

acarbose

Exenatide

Orlistat

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Improvement of pregnant rate after intensive metabolic intervention
To compare the pregnant rate of four groups after treatment

Secondary Outcome Measures

Improvement of obsorbtion rate after intensive metabolic intervention
To compare the obsorbtion rate of four groups after treatment
Improvement of stillborn foetus rate after intensive metabolic intervention
To compare the stillborn foetus rate of four groups after treatment
Improvement of hyperandrogenism
To compare the free androgen index of three groups after treatment
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
To compare the intravenous blood glucose of three groups after treatment
Improvement of triglyceride
To compare the circulating triglyceride of three groups after treatment

Full Information

First Posted
November 28, 2017
Last Updated
December 21, 2017
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03383068
Brief Title
Research of Intensive Metabolic Intervention Before Pregnancy in PCOS
Acronym
PCOS
Official Title
Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Impaired Glucose Tolerance
Keywords
PCOS, imparied glucose tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Description
metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
Arm Title
acarbose
Arm Type
Experimental
Arm 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
Arm Title
Exenatide
Arm Type
Experimental
Arm 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
Arm Title
Orlistat
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Acarbose 100 MG
Other Intervention Name(s)
Acarbose
Intervention Description
for metformin uneffective subjects, using acarbose for 3 months
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
for metformin uneffective subjects, using Exenatide for 3 months
Intervention Type
Drug
Intervention Name(s)
Orlistat
Intervention Description
for metformin uneffective subjects, using Orlistatfor 3 months
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
METF
Intervention Description
metformin effective subjects,act as control group
Primary Outcome Measure Information:
Title
Improvement of pregnant rate after intensive metabolic intervention
Description
To compare the pregnant rate of four groups after treatment
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Improvement of obsorbtion rate after intensive metabolic intervention
Description
To compare the obsorbtion rate of four groups after treatment
Time Frame
up to 24 weeks
Title
Improvement of stillborn foetus rate after intensive metabolic intervention
Description
To compare the stillborn foetus rate of four groups after treatment
Time Frame
up to 24 weeks
Title
Improvement of hyperandrogenism
Description
To compare the free androgen index of three groups after treatment
Time Frame
up to 24 weeks
Title
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
Description
To compare the intravenous blood glucose of three groups after treatment
Time Frame
up to 24 weeks
Title
Improvement of triglyceride
Description
To compare the circulating triglyceride of three groups after treatment
Time Frame
up to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Tao, MD
Phone
86-13817701776
Email
taotaosh76@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Tao, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital Department of Endocrinology and Metabolism
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu, MD
Phone
+86-18918358342
Email
sue_liuwei@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

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