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

NCT04264832 | Completed

• 1 other identifier: Peking TCM
• Study Type: observational
• Target: 733
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• body fat content and ratio

  Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan)

  Baseline

Secondary Outcomes (30)

• Body mass index (BMI)

  Baseline

• Waist circumference(WC)

  Baseline

• Hip circumference

  Baseline

• Waist-hip ratio (WHR)

  Baseline

• Fat content and ratio of trunk

  Baseline

Study Arms (2)

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

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

Interventions

Clinical data collection 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; observation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University third hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (3)

• 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.

  PMID: 40122801 DERIVED

• 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.

  PMID: 39587600 DERIVED

• 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.

  PMID: 36699018 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Haolin Zhang

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: March 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-03

Locations

CN (1)