To Study Polycystic Ovary Syndrome in Taiwanese Women

Metabolic Syndrome Clinical Trial

Official title:

To Study Polycystic Ovary Syndrome in Taiwanese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256944
• Other study ID #: WFH-PCOS-99041
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: December 8, 2015
• Start date: August 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Description:

1. Method

1. This study was approved by the Institutional Review Board of the Wan Fang Medical Center at Taipei Medical University (WF99041, approved August 2010) and performed at the Reproductive Endocrinology Clinic at the Wan Fang Medical Center from 31 August 2010 to 31 August 2011. The following women were excluded: (i) women who had been diagnosed with hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplasia, androgen-secreting tumor,Cushing's syndrome, disorders of the uterus and chromosomal anomalies; (ii) women who were less than three years past menarche or who were older than 45 years; (iii) women who received hormones or medication for major medical diseases (diabetes or cardiovascular disease); and (iv) women who had had ovarian cysts or ovarian tumors identified by ultrasonographic examination.

2. Statistical analysis: We used chi-squared and Fisher's exact tests to perform categorical comparisons and ANOVA to compare the continuous variables. The means of more than two groups were compared using one-way ANOVA and post hoc Dunnett's t-test with equal variances not assumed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• women at reproductive age

• women with PCOS and women without PCOS.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Testosterone	Using serum total testosterone to represent the severity of hyperandrogenism.	1 year	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)	HOMA-IR = [fasting insulin (in µIU/mL) × fasting glucose (in mg/dL)]/405.	1 year	No
Primary	Cholesterol	Hypercholesterolemia was defined as >6 mmol / L.	1 year	No
Primary	Triglycerides	Abnormal serum triglycerides defined as = 1.7 mmol/L	1 year	No
Primary	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	No
Primary	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	No
Primary	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	No