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

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.

Condition or disease Intervention/treatment Phase
PCOS Impaired Glucose Tolerance Drug: Acarbose 100 MG Drug: Exenatide Drug: Orlistat Drug: Metformin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
control
metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
Drug: Metformin
metformin effective subjects,act as control group
Other Name: METF

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
Drug: Acarbose 100 MG
for metformin uneffective subjects, using acarbose for 3 months
Other Name: Acarbose

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
Drug: Exenatide
for metformin uneffective subjects, using Exenatide for 3 months

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
Drug: Orlistat
for metformin uneffective subjects, using Orlistatfor 3 months




Primary Outcome Measures :
  1. Improvement of pregnant rate after intensive metabolic intervention [ Time Frame: up to 24 weeks ]
    To compare the pregnant rate of four groups after treatment


Secondary Outcome Measures :
  1. Improvement of obsorbtion rate after intensive metabolic intervention [ Time Frame: up to 24 weeks ]
    To compare the obsorbtion rate of four groups after treatment

  2. 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

  3. Improvement of hyperandrogenism [ Time Frame: up to 24 weeks ]
    To compare the free androgen index of three groups after treatment

  4. 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

  5. Improvement of triglyceride [ Time Frame: up to 24 weeks ]
    To compare the circulating triglyceride of three groups after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383068


Contacts
Layout table for location contacts
Contact: Tao Tao, MD 86-13817701776 taotaosh76@163.com

Locations
Layout table for location information
China, Shanghai
Renji Hospital Department of Endocrinology and Metabolism Not yet recruiting
Shanghai, Shanghai, China, 200127
Contact: Wei Liu, MD    +86-18918358342    sue_liuwei@163.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tao Tao, MD RenJi Hospital

Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03383068     History of Changes
Other Study ID Numbers: [2017]055
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by RenJi Hospital:
PCOS
imparied glucose tolerance
Additional relevant MeSH terms:
Layout table for MeSH terms
Orlistat
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Exenatide
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents