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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04264832
Other study ID # Peking TCM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date September 1, 2021

Study information

Verified date March 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 733
Est. completion date September 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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 .

Locations

Country Name City State
China Peking University third hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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