Prediction of Immune Status on the Efficacy of Metformin in the 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
- 100
- 试验地点
- 1
- 主要终点
- The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
研究概览
简要总结
In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.
详细描述
In this study, peripheral blood samples of PCOS patients were collected before and after intervention. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •aged 18-45 years
- •Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
排除标准
- •Pregnant women;
- •Hyperthyroidism or hypothyroidism
- •Severe liver and kidney function injury
- •Cancer patients;
- •Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
- •Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
- •Patients with mental illness or intellectual disability;
- •Have taken drugs for PCOS treatment in the last three months;
- •Have a long history of taking hormone therapy;
- •Currently or recently participating in another clinical trial.
研究组 & 干预措施
Metformin therapy
Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment.
干预措施: Metformin (Drug)
结局指标
主要结局
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
时间窗: Samples to be collected once per participant within 7 days of enrollment.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
时间窗: Samples to be collected once per participant within 7 days of enrollment.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
次要结局
- LDL-c(Within 7 days of enrollment.)
- free testosterone(Within 7 days of enrollment.)
- Triglycerides(Within 7 days of enrollment.)
- body mass index(Within 7 days of enrollment.)
- fasting glucose(Within 7 days of enrollment.)
- Total cholesterol(Within 7 days of enrollment.)
- Homeostasis model assessment of insulin resistance(Within 7 days of enrollment.)
- fasting insulin(Within 7 days of enrollment.)
- total testosterone(Within 7 days of enrollment.)
- menstrual frequency(Within 7 days of enrollment.)
- Sex hormone-binding globulin(Within 7 days of enrollment.)
- Androstenedione(Within 7 days of enrollment.)
- HDL-c(Within 7 days of enrollment.)
- Dehydroepiandrosterone(Within 7 days of enrollment.)
研究者
Zhang Manna
Prof.
Shanghai 10th People's Hospital