Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 49 of 69 for:    ORLISTAT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383068
Recruitment Status : Not yet recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date December 26, 2017
Estimated Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
Improvement of pregnant rate after intensive metabolic intervention [ Time Frame: up to 24 weeks ]
To compare the pregnant rate of four groups after treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Improvement of obsorbtion rate after intensive metabolic intervention [ Time Frame: up to 24 weeks ]
    To compare the obsorbtion rate of four groups after treatment
  • Improvement of stillborn foetus rate after intensive metabolic intervention [ Time Frame: up to 24 weeks ]
    To compare the stillborn foetus rate of four groups after treatment
  • Improvement of hyperandrogenism [ Time Frame: 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 [ Time Frame: up to 24 weeks ]
    To compare the intravenous blood glucose of three groups after treatment
  • Improvement of triglyceride [ Time Frame: up to 24 weeks ]
    To compare the circulating triglyceride of three groups after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research of Intensive Metabolic Intervention Before Pregnancy in PCOS
Official Title  ICMJE Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PCOS
  • Impaired Glucose Tolerance
Intervention  ICMJE
  • Drug: Acarbose 100 MG
    for metformin uneffective subjects, using acarbose for 3 months
    Other Name: Acarbose
  • Drug: Exenatide
    for metformin uneffective subjects, using Exenatide for 3 months
  • Drug: Orlistat
    for metformin uneffective subjects, using Orlistatfor 3 months
  • Drug: Metformin
    metformin effective subjects,act as control group
    Other Name: METF
Study Arms  ICMJE
  • control
    metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
    Intervention: Drug: Metformin
  • Experimental: 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
    Intervention: Drug: Acarbose 100 MG
  • Experimental: 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
    Intervention: Drug: Exenatide
  • Experimental: 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
    Intervention: Drug: Orlistat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tao Tao, MD 86-13817701776 taotaosh76@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03383068
Other Study ID Numbers  ICMJE [2017]055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tao Tao, MD RenJi Hospital
PRS Account RenJi Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP