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

Polycystic Ovary Syndrome (PCOS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264832
• Other study ID #: Peking TCM
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

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