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

Completed

• Conditions: Polycystic Ovary Syndrome (PCOS)
• Interventions: Other: Clinical data collection

• Registration Number: NCT04264832
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Status Verified: 2021-03
• Primary Completion: 2021-05-01
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 733

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Clinical data collection	The control group participants are normal women and had no history of any type of diabetes, cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization), stage 2 hypertension , malignant disease or severe renal or hepatic disease. They accepted the same examinations as the observation group.
observation group	Clinical data collection	Participants were eligible if they met the Rotterdam diagnostic criteria of polycystic ovary syndrome (PCOS) and meet the inclusion and exclusion criteria , and all study participants received questionnaires and underwent the physical, transvaginal ultrasound and body composition examination. Blood samples were collected for analysis of metabolic markers, metabonomics and hormones.

Primary Outcome Measures

Name	Time	Method
body fat content and ratio	Baseline	Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)

Secondary Outcome Measures

Name	Time	Method
5- hydroxytryptamine (5-HT)	Baseline	examined with the blood sample
Prolactin (PRL)	Baseline	Examined with the blood sample
triglycerides	Baseline	examined with the blood sample
Dopamine(DA)	Baseline	examined with the blood sample
Waist circumference(WC)	Baseline	Waist 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.
Fat content and ratio of trunk	Baseline	Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)
Body mass index (BMI)	Baseline	Weight in kilograms divided by the square of height in meters, reported in kg/m2
Follicle stimulating hormone (FSH)	Baseline	Examined with the blood sample
luteinizing hormone (LH)	Baseline	Examined with the blood sample
Progestin (P)	Baseline	Examined with the blood sample
HOMA-IR	Baseline	calculation of HOMA-IR: \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5)
total cholesterol	Baseline	examined with the blood sample
Self-Rating Anxiety Scale (SAS)	Baseline	determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.
Preserved Stress Scale (PSS)	Baseline	determine the stress level with the questionnaire of SDS (14-56 score), the higher, the worse
Insulin	Baseline	Examined with the blood sample
β-endorphin	Baseline	examined with the blood sample
Waist-hip ratio (WHR)	Baseline	Waist-to-hip ratio
Estrogen (E2)	Baseline	Examined with the blood sample
Glucose	Baseline	Examined with the blood sample
lipometabonomics	Baseline	examined with the blood sample
short form-36 (SF36)	Baseline	determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better
Hip circumference	Baseline	Hip 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.
Androgen(T)	Baseline	Examined with the blood sample
Androstenedione (A2)	Baseline	Examined with the blood sample
HOMA- β	Baseline	calculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5) (%)
high density lipoprotein (HDL)	Baseline	examined with the blood sample
low density lipoprotein (LDL)	Baseline	examined with the blood sample examined with the blood sample
bile acid	Baseline	examined with the blood sample (fasting plasma glucose (mmol/L) - 3.5) (%)
FerrimanGallwey (FG )value	Baseline	To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse
Self-Rating Depress Scale (SDS)	Baseline	determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse

Trial Locations

Locations (1)

Peking University third hospital; 🇨🇳 Beijing, Beijing, China