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IR, Inflammatory and Cardiovascular Markers in PCOS Among Obese and Non-obese Women

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ClinicalTrials.gov Identifier: NCT01989039
Recruitment Status : Unknown
Verified November 2013 by Ming-I Hsu, Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital

Study Description
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Brief Summary:
FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.

Condition or disease
Polycystic Ovary Syndrome, Insulin Resistance,

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : August 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : July 2014

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women. [ Time Frame: A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 48 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.
Criteria

Inclusion Criteria:

  • Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.

Exclusion Criteria:

  • women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, and chromosomal anomalies;
  • women who had had menarche less than 1 years before evaluation or who were older than 49;
  • women who received hormones or drugs for major medical diseases within three months.
Contacts and Locations
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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): NCT01989039


Contacts
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Contact: Ming I Hsu, MD 886-2-2930-7930 ext 2508 hsumingi@yahoo.com.tw

Locations
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Taiwan
WanFang Medical Center at Taipei Medical University Recruiting
Taipei City, Taiwan, 116
Contact: Ming I Hsu, MD    886-2-2930-7930 ext 2508    hsumingi@yahoo.com.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Principal Investigator: Ming I Hsu, MD Taipei Medical University WanFang Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01989039    
Other Study ID Numbers: Hsu2013-TMU-JIRB201307021
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
 Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases