Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Fibrinogen-like-protein 1 (FGL1)
研究概览
简要总结
The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to promote the realization of more accurate personalized medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18- 45;
排除标准
- •Female patients younger than 18 years old or older than 45 years old;
- •Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction;
- •Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism;
- •Abnormal liver or renal function((≥ 3 times of the upper limit of normal range)
- •Type 1 diabetes, single gene mutation diabetes, or pancreatic damage Diabetes or other secondary diabetes caused by diabetes;
- •History of malignant tumors;
- •Severe infection, severe anemia, neutropenia and other systemic chronic diseases;
- •Undergo total hysterectomy or ovarian adnexectomy;
- •Mental illness, dementia or other cognitive behavioral problems;
- •Use hypoglycemic drugs that may affect insulin resistance and androgen levels in the last 3 months, including thiazolidinediones, metformin, SGLT-2, and acarbose and GLP-1RA and other drugs;
- •Use letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, anti-androgens (spironolactone, Cyproterone acetate, flutamide, etc.) and other drugs for the treatment of PCOS.
研究组 & 干预措施
PCOS
- Oligomenorrhea/amenorrhea
- Clinical androgen excess or biochemical androgen excess
- Polycystic ovary showed by gynecological ultrasound
干预措施: This study does not involve any interventions (Other)
NOPCOS
not meet Rotterdam standards
干预措施: This study does not involve any interventions (Other)
结局指标
主要结局
Fibrinogen-like-protein 1 (FGL1)
时间窗: baseline
Fibrinogen-like-protein 1 (FGL1), is a novel hepatokine that plays an important role in hepatic steatosis, insulin resistance and obesity. There is no maximum or minimum value for this parameter and the higher scores mean a worse outcome.
次要结局
- Waist/hip Ratio,WHR(baseline)
- Ferriman-Gallwey score(Time Frame: baseline)
- Number of menstruation in the last year(baseline)
- TT(baseline)
- LH(baseline)
- FT(baseline)
- AST(baseline)
- CR(baseline)
- LDL-c(baseline)
- HDL-c(baseline)
- Chemerin(baseline)
- RBP-4(baseline)
- body mass index ,BMI(baseline)
- PBG(baseline)
- SHBG(baseline)
- HOMA-IR(baseline)
- Interleukin 22#IL-22(baseline)
- omentin-1(baseline)
- leptin(baseline)
- adiponectin(baseline)
- DHEAS(baseline)
- FSH(baseline)
- FINS(baseline)
- PINS(baseline)
- ALT(baseline)
- UA(baseline)
- TG(baseline)
- Tumor Necrosis Factor# TNF(baseline)
- FBG(baseline)
- TC(baseline)
- Interleukin 6#IL-6(baseline)
- Interleukin 8# IL-8(baseline)
研究者
Zhang Manna
Director, Principal Investigator, Clinical Professor
Shanghai 10th People's Hospital