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Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome

Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04264832
Enrollment
733
Registered
2020-02-11
Start date
2016-03-01
Completion date
2021-09-01
Last updated
2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

fat distribution, insulin resistance, negative emotion, polycystic ovary syndrome (PCOS)

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.

Interventions

Basic characteristics: Participants were carefully characterized with regard to a general health history, a medical history, clinical, demographic and anthropomorphic measurements, skin problems (hirsutism is modified by Ferriman-Gallwey (mF-G) score , global acne score and premature alopecia). A transvaginal ultrasound scan was performed on every participant during a clinical examination to determine the number of follicles and ovarian volume. Metabolic and other assessments: General gynecological examination, prolactin, thyroid, androgen, LH, FSH, DA, 5-HT, metabonomics, glucose, insulin, triglyceride (TG), LDL and HDL were determined, OGTT was performed. Questionnaires: The perceived stress scale(Chinese 14-item PSS), self-rating anxiety scale (SAS), self-rating depressive scale(SDS) were used to assess the participants' mental health status. The MOS item short from health survey (SF-36) was used to assess the quality of life .

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
body fat content and ratioBaselineExamined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)

Secondary

MeasureTime frameDescription
Waist circumference(WC)BaselineWaist circumference(WC)reported in cm, refers to the horizontal circumference along the midpoint of the connection line of the anterior superior iliac crest through the lower costal margin of the calm breathing state when standing. Recumbent position is the abdominal circumference through the girth of the navel.
Hip circumferenceBaselineHip circumference reported in cm, and when measured, the legs are upright and closed together, the arms are naturally pendulous, and the tape measure is placed horizontally on the pubic symphysis in front and the gluteus maximus in the back.
Waist-hip ratio (WHR)BaselineWaist-to-hip ratio
Fat content and ratio of trunkBaselineExamined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)
Follicle stimulating hormone (FSH)BaselineExamined with the blood sample
luteinizing hormone (LH)BaselineExamined with the blood sample
Progestin (P)BaselineExamined with the blood sample
Estrogen (E2)BaselineExamined with the blood sample
Prolactin (PRL)BaselineExamined with the blood sample
Androgen(T)BaselineExamined with the blood sample
Androstenedione (A2)BaselineExamined with the blood sample
GlucoseBaselineExamined with the blood sample
InsulinBaselineExamined with the blood sample
HOMA-IRBaselinecalculation of HOMA-IR: \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5)
Body mass index (BMI)BaselineWeight in kilograms divided by the square of height in meters, reported in kg/m2
total cholesterolBaselineexamined with the blood sample
triglyceridesBaselineexamined with the blood sample
high density lipoprotein (HDL)Baselineexamined with the blood sample
low density lipoprotein (LDL)Baselineexamined with the blood sample examined with the blood sample
β-endorphinBaselineexamined with the blood sample
5- hydroxytryptamine (5-HT)Baselineexamined with the blood sample
Dopamine(DA)Baselineexamined with the blood sample
lipometabonomicsBaselineexamined with the blood sample
bile acidBaselineexamined with the blood sample (fasting plasma glucose (mmol/L) - 3.5) (%)
FerrimanGallwey (FG )valueBaselineTo determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse
short form-36 (SF36)Baselinedetermine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better
Self-Rating Anxiety Scale (SAS)Baselinedetermine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.
Self-Rating Depress Scale (SDS)Baselinedetermine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse
Preserved Stress Scale (PSS)Baselinedetermine the stress level with the questionnaire of SDS (14-56 score), the higher, the worse
HOMA- βBaselinecalculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5) (%)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026