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Clinical Trials/NCT01113918
NCT01113918
Completed
Not Applicable

A Study of Clinical Presentation and Cardiovascular Disease of Hyperandrogenism and Polycystic Ovary Syndrome in Obese and Non-obese Taiwanese Women

Taipei Medical University WanFang Hospital1 site in 1 country627 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovary Syndrome
Sponsor
Taipei Medical University WanFang Hospital
Enrollment
627
Locations
1
Primary Endpoint
Obese
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are potentially dangerous in women health. Early diagnosis and prevention is very important to the PCOS patients.

Obesity is the most potential risk of threat to health of populations. There is a major impact of obesity on the PCOS related disorders. Insulin resistance and distribution of adipose tissue were thought to be the important risk factors of cardiovascular and metabolic syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team. We recently published in "Fertility and Sterility" about the clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is important to know that some clinical presentation of PCOS might have ethic variance. Insulin resistance was reported as another candidate that might have ethic variance.We had reported about 40% women in PCOS women were obese, it is similar with previous literature reported. Obesity is a major factor that could be controlled during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS women would be facing the risks of diabetes and metabolic syndrome.We thought like to evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.

Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of cardiovascular disease, we would like to know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research which including gynecological endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This team had been working well for more that 4 years.

We hope we can make a contribution to the study and treatment of PCOS in Taiwan.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
February 2010
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ming-I Hsu

Attending Doctor

Taipei Medical University WanFang Hospital

Eligibility Criteria

Inclusion Criteria

  • women who had visited the Reproductive Endocrinology Clinic at Taipei Medical University - Wan Fang Medical Center during April 2004 - March 2007 with the chief complaints of menstrual irregularities, infertility, acne/or hirsutism.

Exclusion Criteria

  • women who had been diagnosed with androgen-secreting tumors.
  • girls who had their menarche less than 3 years prior to the study, or who older than
  • women with inadequate clinical/biochemical records.

Outcomes

Primary Outcomes

Obese

Time Frame: Who had visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center during April 2004 - March 2007.

Study Sites (1)

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