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.

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome (PCOS)
• Intervention / Treatment: Other: Clinical data collection

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 Type: Observational
• Enrollment (Actual): 733

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observation group; 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.	Other: Clinical data collection; 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 .
control group; 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.	Other: Clinical data collection; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body fat content and ratio	Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Haolin Zhang, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome (PCOS); insulin resistance; fat distribution; negative emotion
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: Peking TCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We haven't decided whether to share the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No