Obesity and Clinical Presentation of Hyperandrogenism

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01114633
Collaborator
(none)
46
1
12
3.8

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. The investigators 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. The investigators 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. The investigators 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, the investigators 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.

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    46 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Obesity and Clinical Presentation of Hyperandrogenism
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Apr 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      15 Years to 45 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Acne and/or hirsutism
      Exclusion Criteria:
      • Male

      • Menopause

      • Tumor

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Taipei Medical University WanFang Hospital Taipei Taiwan 116

      Sponsors and Collaborators

      • Taipei Medical University WanFang Hospital

      Investigators

      • Principal Investigator: Ming-I Hsu, MD, Taipei Medical University WanFang Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital
      ClinicalTrials.gov Identifier:
      NCT01114633
      Other Study ID Numbers:
      • WFH-PCOS-98039
      First Posted:
      May 3, 2010
      Last Update Posted:
      Nov 6, 2013
      Last Verified:
      Nov 1, 2013
      Keywords provided by Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Nov 6, 2013