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

NCT ID: NCT04264832

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 733 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2021-09-01

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Clinical data collection

Intervention Type: OTHER

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.

Clinical data collection

Intervention Type: OTHER

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 .

Interventions

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 .

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haolin Zhang

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

Peking University third hospital

Beijing, Beijing Municipality, China

Countries

China

References

Yang S, Zhang H, Shi L, Yang Y, Lu Y, Qiu W, Fukuzawa I, Zhou L, Xin X, Ding N, Luo L, Wang W, Zhang H. Menstrual disorder is associated with blood type in PCOS patients: evidence from a cross-sectional survey. BMC Endocr Disord. 2025 Mar 24;25(1):77. doi: 10.1186/s12902-025-01898-0.

Reference Type: DERIVED

PMID: 40122801 (View on PubMed)

Zhang H, Qiu W, Zhou P, Shi L, Chen Z, Yang Y, Lu Y, Zhou L, Zhang H, Cheng M, Ye Y, Li R. Obesity is associated with SHBG levels rather than blood lipid profiles in PCOS patients with insulin resistance. BMC Endocr Disord. 2024 Nov 25;24(1):254. doi: 10.1186/s12902-024-01789-w.

Reference Type: DERIVED

PMID: 39587600 (View on PubMed)

Zhang H, Wang W, Zhao J, Jiao P, Zeng L, Zhang H, Zhao Y, Shi L, Hu H, Luo L, Fukuzawa I, Li D, Li R, Qiao J. Relationship between body composition, insulin resistance, and hormonal profiles in women with polycystic ovary syndrome. Front Endocrinol (Lausanne). 2023 Jan 9;13:1085656. doi: 10.3389/fendo.2022.1085656. eCollection 2022.

Reference Type: DERIVED

PMID: 36699018 (View on PubMed)

Other Identifiers

Peking TCM

Identifier Type: -

Identifier Source: org_study_id