To Study Polycystic Ovary Syndrome in Taiwanese Women

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Taipei Medical University WanFang Hospital

临床试验: NCT01256944

BioSeek: nct01256944

关键词

抽象

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.

描述

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.

日期

最后验证:	11/30/2015
首次提交:	12/06/2010
提交的预估入学人数:	12/07/2010
首次发布:	12/08/2010
上次提交的更新:	12/07/2015
最近更新发布:	01/12/2016
首次提交结果的日期:	11/27/2013
首次提交质量检查结果的日期:	12/07/2015
首次发布结果的日期:	01/12/2016
实际学习开始日期:	07/31/2010
预计主要完成日期:	05/31/2013
预计完成日期:	05/31/2013

状况或疾病

Polycystic Ovary Syndrome

Metabolic Syndrome

Cardiovascular Disease

相

手臂组

臂	干预/治疗
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: Oligo- or anovulation Clinical and/or biochemical signs of hyperandrogenism Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)

资格标准

有资格学习的年龄	15 Years 至 15 Years
有资格学习的性别	Female
取样方式	Probability Sample
接受健康志愿者	是
标准	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.

结果

主要结果指标

1. Total Testosterone [1 year]

Using serum total testosterone to represent the severity of hyperandrogenism.

2. BMI [1 year]

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).

3. Fasting Insulin [1 year]

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.

4. Fasting Glucose [1 year]

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).

5. Two Hour Glucose [1 year]

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).

6. Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) [1 year]

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

7. Cholesterol [1 year]

Hypercholesterolemia was defined as >6 mmol / L.

8. Triglycerides [1 year]

Abnormal serum triglycerides defined as ≥ 1.7 mmol/L

9. HDL [1 year]

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.

10. LDL [1 year]

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.

11. Impaired Glucose Tolerance [1 years]

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.

To Study Polycystic Ovary Syndrome in Taiwanese Women

关键词

ovarian neoplasms

neoplasms

ovarian cysts

cysts

hyperplasia

amenorrhea

oligomenorrhea

hirsutism

hyperprolactinemia

primary ovarian insufficiency

anovulation

hyperandrogenism

insulin resistance

obesity

hypogonadism

抽象

描述

日期

状况或疾病

相

手臂组

资格标准

结果

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