Effects of Metformin on Metabolic and Reproductive Outcomes in Chinese PCOS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 1,440
- 试验地点
- 1
- 主要终点
- Reversed insulin resistance or restored glucose homeostasis in women with PCOS
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a reproductive endocrine disease characterized by reproductive and metabolic abnormalities, which is a crucial cause of female infertility and an essential risk factor for type 2 diabetes. At present, there exist several clinical trials and studies on the usage of metformin in the treatment of PCOS patients in prediabetes, and the practical application of metformin in clinical practice has years of history. The treatment plan of metformin is of great significance in preventing type 2 diabetes in PCOS patients and assisting pregnancy in PCOS infertile patients.
详细描述
The purpose of this study is to conduct a real world study on effects of metformin on the improvement of metabolism and reproductive outcome in Chinese prediabetic PCOS patients by collecting relevant medical system records from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine as real world data and a significant supplement to clinical trial studies. At the same time, obese and non-obese PCOS patients may have different mechanisms of insulin resistance, so this study stratified PCOS patients to analyze whether metformin can improve treatment results for PCOS patients with prediabetes according to different body mass index (BMI).The investigator's study is the first real world study to investigate Chinese pre-diabetes PCOS patients treated by metformin and the metabolic and reproductive outcomes, which is innovative. The investigator's research also has a guiding significance for the practical application of metformin in improving glucose metabolism and reproductive outcomes in patients with different body weight in clinical practice, and has great relevance for PCOS patients to reduce long-term complications and improve quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females at the age of 18-45years old;
- •Diagnosed with PCOS or/and impaired glucose regulation (IGR)/diabetes(DM)
- •Metformin regimens were used without other metabolic agents
- •The diagnosis of PCOS is based on the 2003 Rotterdam criteria and the diagnostic criteria for impaired glucose regulation (IGR) and type 2 diabetes are based on the 2021 American Diabetes Association(ADA) diagnosis criteria.
排除标准
- •Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit of normal, or Cr>132umol/l, or eGFR <60 mL/min/1.73m2), psychosis, accompanied by severe infection, severe anemia, neutropenia disease;
- •Participated in clinical trials of other drugs within 3 months;
- •In the past 5 years, there have been treated or untreated organ system tumors (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
- •A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
- •Any conditions judged by the investigator that affect enrollment.
研究组 & 干预措施
BMI<24 kg/m2
women diagnosed with PCOS with BMI<24 kg/m2
干预措施: Metformin (Drug)
BMI24-28 kg/m2
women diagnosed with PCOS with BMI24-28 kg/m2
干预措施: Metformin (Drug)
BMI>28 kg/m2
women diagnosed with PCOS with BMI>28kg/m2
干预措施: Metformin (Drug)
结局指标
主要结局
Reversed insulin resistance or restored glucose homeostasis in women with PCOS
时间窗: 5 years
Compared with the baseline in three groups, the rate of reversed insulin resistance or restored glucose homeostasis
次要结局
- change in the level of BMI(5 years)
- change in the level of glycated hemoglobin(HbA1c)(5 years)
- change in the level of 0'-180'Plasma Glucose(PG)(5 years)
- change in the level of 0'-180'insulin(ins)(5 years)
- change in the level of 0'-180'C-Peptide(5 years)
- change in the level of β cell homeostatic model assessment(HOMA-β)(5 years)
- change in the level of Matsuda Index(MI)(5 years)
- change in the level of deposition index(DI)(5 years)
- change in the level of Prolactin(PRL)(5 years)
- change in the level of waist-hip ratio(WHR)(5 years)
- change in the level of estradiol(E2)(5 years)
- change in the level of Luteinizing hormone(LH)(5 years)
- change in the level of Follicle stimulating hormone(FSH)(5 years)
- change in the level of testosterone(T)(5 years)
- change in the level of Sex hormone-binding globulin(SHBG)(5 years)
- change in the level of Dehydroepiandrosterone sulfate(DHEAS)(5 years)
- change in the level of Androstenedione(A2)(5 years)
- pregnancy rate(5 years)
- live birth rate(5 years)
- improvement rate of menstrual cycle(5 years)