NCT03383068

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

November 28, 2017

Last Update Submit

December 21, 2017

Conditions

PCOSImpaired Glucose Tolerance

Keywords

PCOSimparied glucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Improvement of pregnant rate after intensive metabolic intervention

    To compare the pregnant rate of four groups after treatment

    up to 24 weeks

Secondary Outcomes (5)

  • Improvement of obsorbtion rate after intensive metabolic intervention

    up to 24 weeks

  • Improvement of stillborn foetus rate after intensive metabolic intervention

    up to 24 weeks

  • Improvement of hyperandrogenism

    up to 24 weeks

  • Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation

    up to 24 weeks

  • Improvement of triglyceride

    up to 24 weeks

Study Arms (4)

control

OTHER

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

Drug: Metformin

acarbose

EXPERIMENTAL

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

Drug: Acarbose 100 MG

Exenatide

EXPERIMENTAL

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

Drug: Exenatide

Orlistat

EXPERIMENTAL

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

Drug: Orlistat

Interventions

Acarbose 100 MGDRUG

for metformin uneffective subjects, using acarbose for 3 months

Also known as: Acarbose
acarbose
ExenatideDRUG

for metformin uneffective subjects, using Exenatide for 3 months

Exenatide
OrlistatDRUG

for metformin uneffective subjects, using Orlistatfor 3 months

Orlistat
MetforminDRUG

metformin effective subjects,act as control group

Also known as: METF
control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS women at Childbearing Age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

AcarboseExenatideOrlistatMetformin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsLactonesOrganic ChemicalsBiguanidesGuanidinesAmidines

Study Officials

  • Tao Tao, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Tao, MD

CONTACT

86-13817701776taotaosh76@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 26, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

June 30, 2020

Last Updated

December 26, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)