Expression of CVD and HA Between Obesity and Non-obesity Polycystic Ovary Syndrome (PCOS) Women in Taiwan

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01113918

Collaborator

(none)

627

Enrollment

Location

Duration (Months)

52.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

627 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Obsity PCOS Women Polycystic ovary syndrome (PCOS) was diagnosed according to the European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM) case definition which requires presentation of signs and/or symptoms of a minimum of 2 of the following 3 criteria: polycystic ovary morphology (PCOM), oligomenorrhea or amenorrhea (Oligo-An), androgen excess (HA). Body mass index (BMI) was defined as body weight in kilograms divided by body height in meters squared (kg/m2). Obesity was defined as BMI≥25 kg/m2, according to the Asia-Pacific definition.
Non-obesity PCOS Women The subjects BMI were less than ≥25 kg/m2 and out of criteria of PCOS by European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM).

Arm

Intervention/Treatment

Obsity PCOS Women

Polycystic ovary syndrome (PCOS) was diagnosed according to the European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM) case definition which requires presentation of signs and/or symptoms of a minimum of 2 of the following 3 criteria: polycystic ovary morphology (PCOM), oligomenorrhea or amenorrhea (Oligo-An), androgen excess (HA). Body mass index (BMI) was defined as body weight in kilograms divided by body height in meters squared (kg/m2). Obesity was defined as BMI≥25 kg/m2, according to the Asia-Pacific definition.

Non-obesity PCOS Women

The subjects BMI were less than ≥25 kg/m2 and out of criteria of PCOS by European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM).

Outcome Measures

Primary Outcome Measures

Obese [Who had visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center during April 2004 - March 2007.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.