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临床试验/NCT05063383
NCT05063383招募中不适用

Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
diagnostic markers of PCOS patients

研究概览

简要总结

The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome in this study, used statistical software such as SPSS for data analysis, and used experimental techniques such as ELISA to detect serum samples, aiming to explore the relationship between the body anthropometry, glucose and lipid metabolism, gonadal hormones and body fat distribution in patients with polycystic ovary syndrome and to discovery new biomarkers and 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

入选标准

  • Female aged 18- 45;
  • Meet Rotterdam criteria;

排除标准

  • Women who are pregnant or have a pregnancy plan within six months;
  • Congenital adrenocortical hyperplasia;
  • Hyperprolactinemia;
  • Hyperthyroidism or hypothyroidism;
  • Abnormal liver function (≥ 3 times of the upper limit of normal range);
  • Abnormal renal function (GFR<60ml/min/1.73m2);
  • Adrenal or ovarian tumors secreting androgens;
  • Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.

结局指标

主要结局

diagnostic markers of PCOS patients

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

  • FSH(baseline)
  • DHEAS(baseline)
  • PINS,(baseline)
  • TC(baseline)
  • Interleukin 6,IL-6(baseline)
  • body mass index ,BMI(baseline)
  • Number of menstruation in the last year(baseline)
  • RBP-4(baseline)
  • adiponectin(baseline)
  • HOMA-IR(baseline)
  • TT(baseline)
  • FT(baseline)
  • SHBG(baseline)
  • ALT(baseline)
  • CR(baseline)
  • HDL-c(baseline)
  • LH(baseline)
  • FBG(baseline)
  • AST(baseline)
  • LDL-c(baseline)
  • TG(baseline)
  • Chemerin(baseline)
  • omentin-1(baseline)
  • Apelin(baseline)
  • Waist/hip Ratio,WHR(baseline)
  • Ferriman-Gallwey score(baseline)
  • PBG(baseline)
  • FINS(baseline)
  • UA(baseline)
  • Tumor Necrosis Factor, TNF(baseline)
  • leptin(baseline)
  • resistin(baseline)
  • Visfatin(baseline)
  • Vaspin.(baseline)
  • Interleukin 22,IL-22(baseline)
  • Interleukin 8, IL-8(baseline)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Manna

Director, Principal Investigator, Clinical Professor

Shanghai 10th People's Hospital

研究点 (1)

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