To Study Polycystic Ovary Syndrome in Taiwanese Women

NCT01256944 | Completed Results

• 1 other identifier: WFH-PCOS-99041
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. Of those diagnosed with PCOS using the 2003 Rotterdam criteria, 61% fulfilled 1990 NIH criteria for unexplained hyperandrogenic chronic anovulation. The patient populations with the new phenotypes had less severe ovulatory dysfunction and less androgen excess than patients diagnosed using the 1990 NIH criteria. These findings might be common across all female populations with PCOS, whether in Oriental or Occidental countries. Data for clinical hyperandrogenism indicated that the prevalence of hirsutism in Taiwanese PCOS women is lower than that for Caucasians/Western women. The extent of metabolic abnormalities in women with PCOS may vary with phenotype, age and ethnicity. Obesity represents a major risk factor for metabolic syndrome and insulin resistance. Approximately 40-50% of all women with PCOS are overweight or obese. Obese subjects with PCOS had a higher risk of developing oligomenorrhea, amenorrhea and biochemical hyperandrogenemia than non-obese women with PCOS. Moreover, obese women with PCOS had significantly more severe insulin resistance, lower serum LH levels, and lower LH-to-FSH ratios than non-obese women with PCOS. PCOS women in Taiwan presented with higher LH-to-FSH ratio and lower insulin resistance than PCOS women in Western Countries. However, the average body mass index (BMI) was significantly lower in Taiwanese PCOS women than Western women, which might partially explain the difference between these two populations in terms of clinical and biochemical presentations. To further document the ethnic variation between women with PCOS in Taiwan and Western, the effect of obesity on the diagnosis and clinical presentations of PCOS-related syndromes should not be neglected in future studies. Therefore, the investigators plan to do this prospective study for evaluation the clinical and biochemical presentation of Taiwanese women with PCOS.

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome; Cardiovascular Disease

Keywords

PCOS; DM; Hypertension; CVD

Outcome Measures

Primary Outcomes (11)

• Total Testosterone

  Using serum total testosterone to represent the severity of hyperandrogenism.

  1 year

• BMI

  BMI categorization was based on the WHO Asia-Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).

  1 year

• Fasting Insulin

  A fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.

  1 year

• Fasting Glucose

  Fasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes. World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L).

  1 year

• Two Hour Glucose

  2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes. World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L).

  1 year

• Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)

  HOMA-IR = \[fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)\]/405.

  1 year

• Cholesterol

  Hypercholesterolemia was defined as \>6 mmol / L.

  1 year

• Triglycerides

  Abnormal serum triglycerides defined as ≥ 1.7 mmol/L

  1 year

• HDL

  Metabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria: abdominal obesity (waist circumference \>80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL\<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L.

  1 year

• LDL

  Lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG). Abnormal LDL was ≧4.14mmol/L.

  1 year

• Impaired Glucose Tolerance

  Impaired glucose tolerance was defined as two hour glucose levels of 7.8-11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be \<7 mmol/L.

  1 years

Study Arms (2)

Control

The normal reproductive-aged women

PCOS

Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria: 1. Oligo- or anovulation 2. Clinical and/or biochemical signs of hyperandrogenism 3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Polycystic Ovary Syndrome(PCOS)

You may qualify if:

• women at reproductive age
• women with PCOS and women without PCOS.

You may not qualify if:

• young women who had their menarche less than 3 years
• women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University-WanFang Hospital

Taipei, Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome; Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Ming-I Hsu
• Organization: Taipei Medical University - WanFang Hospital

hsumigni@yahoo.com.tw

886-2-2930-7930

Study Officials

• Ming-I Hsu, MD

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 9, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 13, 2016
• Results First Posted: January 13, 2016

Record last verified: 2015-12

Locations

TW (1)