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Polycystic Ovary Syndrome (PCOS)NCT04264832

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

An observational study of Polycystic Ovary Syndrome (PCOS), run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome (PCOS)
What is being tested?
Clinical data collection
How many people
733 participants
Where
1 siteChina
Study dates
1 Mar 2016to 1 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: a cross-sectional study was conducted in women of reproductive age (19- 45 years) from the Peking university third hospital

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University third hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Clinical data collection
Keywords
fat distribution, insulin resistance, negative emotion, polycystic ovary syndrome (PCOS)
Medical subject headings
Polycystic Ovary Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical data collectionOther

    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 .

Study groups in NCT04264832
Study groupRoleWhat they receive
observation groupParticipants 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.
Receives: Other: Clinical data collection
control groupThe 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.
Receives: Other: Clinical data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body fat content and ratio

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

    Measured: Baseline

Secondary outcomes (30)

  1. Body mass index (BMI)

    Weight in kilograms divided by the square of height in meters, reported in kg/m2

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. Waist-hip ratio (WHR)

    Waist-to-hip ratio

    Measured: Baseline

  5. Fat content and ratio of trunk

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

    Measured: Baseline

  6. Follicle stimulating hormone (FSH)

    Examined with the blood sample

    Measured: Baseline

  7. luteinizing hormone (LH)

    Examined with the blood sample

    Measured: Baseline

  8. Progestin (P)

    Examined with the blood sample

    Measured: Baseline

  9. Estrogen (E2)

    Examined with the blood sample

    Measured: Baseline

  10. Prolactin (PRL)

    Examined with the blood sample

    Measured: Baseline

  11. Androgen(T)

    Examined with the blood sample

    Measured: Baseline

  12. Androstenedione (A2)

    Examined with the blood sample

    Measured: Baseline

  13. Glucose

    Examined with the blood sample

    Measured: Baseline

  14. Insulin

    Examined with the blood sample

    Measured: Baseline

  15. HOMA-IR

    calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)

    Measured: Baseline

  16. HOMA- β

    calculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5) (%)

    Measured: Baseline

  17. total cholesterol

    examined with the blood sample

    Measured: Baseline

  18. triglycerides

    examined with the blood sample

    Measured: Baseline

  19. high density lipoprotein (HDL)

    examined with the blood sample

    Measured: Baseline

  20. low density lipoprotein (LDL)

    examined with the blood sample examined with the blood sample

    Measured: Baseline

  21. β-endorphin

    examined with the blood sample

    Measured: Baseline

  22. 5- hydroxytryptamine (5-HT)

    examined with the blood sample

    Measured: Baseline

  23. Dopamine(DA)

    examined with the blood sample

    Measured: Baseline

  24. lipometabonomics

    examined with the blood sample

    Measured: Baseline

  25. bile acid

    examined with the blood sample (fasting plasma glucose (mmol/L) - 3.5) (%)

    Measured: Baseline

  26. FerrimanGallwey (FG )value

    To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse

    Measured: Baseline

  27. short form-36 (SF36)

    determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better

    Measured: Baseline

  28. Self-Rating Anxiety Scale (SAS)

    determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.

    Measured: Baseline

  29. Self-Rating Depress Scale (SDS)

    determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse

    Measured: Baseline

  30. Preserved Stress Scale (PSS)

    determine the stress level with the questionnaire of SDS (14-56 score), the higher, the worse

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start1 Mar 2016
  3. Primary completion1 May 2021
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
733 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264832
Sponsor's protocol ID
Peking TCM
Status last verified
Mar 2021
First submitted
7 Feb 2020
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We haven't decided whether to share the data

Publications

  • 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.

    PubMed 40122801

  • 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.

    PubMed 39587600

  • 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.

    PubMed 36699018

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome (PCOS), run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body fat content and ratio (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264832, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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