Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 733
- 试验地点
- 1
- 主要终点
- body fat content and ratio
研究概览
简要总结
To investigate the body fat distribution in chinese women with polycystic ovary syndrome (PCOS) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state.
详细描述
The polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders in women of reproductive age. It is also one of the leading causes of anovulatory infertility and secondary amenorrhea, which represent major stress factors in the female life. In the previous studies, the investigators found that PCOS patients showed decreased quality-of-life and increased psychological disturbances compared with healthy controls. Body mass index (BMI) was associated with emotional disorders and physical aspects of quality-of-life and negative emotions were negatively correlated with BMI in PCOS patients.These results prompted that PCOS could be separated into at least two subtypes by the fat content. So the investigators expand the epidemiological investigation for comparing the body composition between the PCOS and the normal women, and finding specific biological indicators in different subtypes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 45 years
- •For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
排除标准
- •Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
- •Type I diabetes or not well controlled type II diabetes
- •Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
- •Psychiatric diagnoses or using psychiatric medications including antidepressants
- •Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
- •The control group are non- PCOS normal women (age 18-45) and meet the same exclusion criteria.
结局指标
主要结局
body fat content and ratio
时间窗: Baseline
Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)
次要结局
- Waist circumference(WC)(Baseline)
- Fat content and ratio of trunk(Baseline)
- Prolactin (PRL)(Baseline)
- triglycerides(Baseline)
- Dopamine(DA)(Baseline)
- β-endorphin(Baseline)
- Body mass index (BMI)(Baseline)
- Follicle stimulating hormone (FSH)(Baseline)
- luteinizing hormone (LH)(Baseline)
- Progestin (P)(Baseline)
- HOMA-IR(Baseline)
- total cholesterol(Baseline)
- Self-Rating Anxiety Scale (SAS)(Baseline)
- Preserved Stress Scale (PSS)(Baseline)
- Insulin(Baseline)
- Waist-hip ratio (WHR)(Baseline)
- Estrogen (E2)(Baseline)
- Glucose(Baseline)
- 5- hydroxytryptamine (5-HT)(Baseline)
- lipometabonomics(Baseline)
- short form-36 (SF36)(Baseline)
- Hip circumference(Baseline)
- Androgen(T)(Baseline)
- Androstenedione (A2)(Baseline)
- HOMA- β(Baseline)
- high density lipoprotein (HDL)(Baseline)
- low density lipoprotein (LDL)(Baseline)
- bile acid(Baseline)
- FerrimanGallwey (FG )value(Baseline)
- Self-Rating Depress Scale (SDS)(Baseline)