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NCT Number: NCT04264832

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University third hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Primary outcomes

  1. body fat content and ratio

    Time frame: Baseline

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

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: Baseline

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

  2. Waist circumference(WC)

    Time frame: 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.

  3. Hip circumference

    Time frame: 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.

  4. Waist-hip ratio (WHR)

    Time frame: Baseline

    Waist-to-hip ratio

  5. Fat content and ratio of trunk

    Time frame: Baseline

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

  6. Follicle stimulating hormone (FSH)

    Time frame: Baseline

    Examined with the blood sample

  7. luteinizing hormone (LH)

    Time frame: Baseline

    Examined with the blood sample

  8. Progestin (P)

    Time frame: Baseline

    Examined with the blood sample

  9. Estrogen (E2)

    Time frame: Baseline

    Examined with the blood sample

  10. Prolactin (PRL)

    Time frame: Baseline

    Examined with the blood sample

  11. Androgen(T)

    Time frame: Baseline

    Examined with the blood sample

  12. Androstenedione (A2)

    Time frame: Baseline

    Examined with the blood sample

  13. Glucose

    Time frame: Baseline

    Examined with the blood sample

  14. Insulin

    Time frame: Baseline

    Examined with the blood sample

  15. HOMA-IR

    Time frame: Baseline

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

  16. HOMA- β

    Time frame: Baseline

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

  17. total cholesterol

    Time frame: Baseline

    examined with the blood sample

  18. triglycerides

    Time frame: Baseline

    examined with the blood sample

  19. high density lipoprotein (HDL)

    Time frame: Baseline

    examined with the blood sample

  20. low density lipoprotein (LDL)

    Time frame: Baseline

    examined with the blood sample examined with the blood sample

  21. β-endorphin

    Time frame: Baseline

    examined with the blood sample

  22. 5- hydroxytryptamine (5-HT)

    Time frame: Baseline

    examined with the blood sample

  23. Dopamine(DA)

    Time frame: Baseline

    examined with the blood sample

  24. lipometabonomics

    Time frame: Baseline

    examined with the blood sample

  25. bile acid

    Time frame: Baseline

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

  26. FerrimanGallwey (FG )value

    Time frame: Baseline

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

  27. short form-36 (SF36)

    Time frame: Baseline

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

  28. Self-Rating Anxiety Scale (SAS)

    Time frame: Baseline

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

  29. Self-Rating Depress Scale (SDS)

    Time frame: Baseline

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

  30. Preserved Stress Scale (PSS)

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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