Clinical trial NCT04264832: Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome
Official title: Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: fat distribution
insulin resistance
negative emotion
polycystic ovary syndrome (PCOS)
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 733
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a cross-sectional study was conducted in women of reproductive age (19- 45 years) from the Peking university third hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: body fat content and ratio
timeFrame: Baseline
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Waist circumference(WC)
timeFrame: Baseline
measure: Hip circumference
timeFrame: Baseline
measure: Waist-hip ratio (WHR)
timeFrame: Baseline
measure: Fat content and ratio of trunk
timeFrame: Baseline
measure: Follicle stimulating hormone (FSH)
timeFrame: Baseline
measure: luteinizing hormone (LH)
timeFrame: Baseline
measure: Progestin (P)
timeFrame: Baseline
measure: Estrogen (E2)
timeFrame: Baseline
measure: Prolactin (PRL)
timeFrame: Baseline
measure: Androgen(T)
timeFrame: Baseline
measure: Androstenedione (A2)
timeFrame: Baseline
measure: Glucose
timeFrame: Baseline
measure: Insulin
timeFrame: Baseline
measure: HOMA-IR
timeFrame: Baseline
measure: HOMA- β
timeFrame: Baseline
measure: total cholesterol
timeFrame: Baseline
measure: triglycerides
timeFrame: Baseline
measure: high density lipoprotein (HDL)
timeFrame: Baseline
measure: low density lipoprotein (LDL)
timeFrame: Baseline
measure: β-endorphin
timeFrame: Baseline
measure: 5- hydroxytryptamine (5-HT)
timeFrame: Baseline
measure: Dopamine(DA)
timeFrame: Baseline
measure: lipometabonomics
timeFrame: Baseline
measure: bile acid
timeFrame: Baseline
measure: FerrimanGallwey (FG )value
timeFrame: Baseline
measure: short form-36 (SF36)
timeFrame: Baseline
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: Baseline
measure: Self-Rating Depress Scale (SDS)
timeFrame: Baseline
measure: Preserved Stress Scale (PSS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Haolin Zhang
role: STUDY_DIRECTOR
References: