NCT05802212已完成不适用
Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Luteinizing hormone in serum
研究概览
简要总结
The purpose of the study is to understand the effect of Metformin on patients with PCOS.
详细描述
This study aims to evaluate the effects of Metformin on reproductive endocrine and reproductive outcomes in women with PCOS, and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
- •Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
- •Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention.
- •Volunteers with polycystic ovary syndrome without insulin resistance.
排除标准
- •Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- •Individuals who are during pregnant, lactation or menopause.
- •Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- •Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
- •Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- •Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
- •Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- •A medical history of severe cardiovascular and cerebrovascular diseases.
- •Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- •Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- •Individuals who need drug treatment for any mental illness such as epilepsy and depression.
- •Cancer patients.
- •Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
研究组 & 干预措施
Metformin intervention for 12 weeks
Experimental
Metformin intervention for 12 weeks
干预措施: Metformin intervention for 12 weeks (Drug)
结局指标
主要结局
Luteinizing hormone in serum
时间窗: before and after 2, 12 weeks of intervention
Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
4-Androstenedione in serum
时间窗: before and after 2, 12 weeks of intervention
Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
次要结局
- Testosterone in serum(before and after 2, 12 weeks of intervention)
- Estradiol in serum(before and after 2, 12 weeks of intervention)
- Prolactin in serum(before and after 2, 12 weeks of intervention)
- Follicle number(before intervention)
- Ovarian volume(before intervention)
- The alterations of plasma lipid metabolites(before intervention)
- Fasting insulin(before and after 2, 12 weeks of intervention)
- Blood sugar level(before and after 2, 12 weeks of intervention)
- The alterations of secondary metabolites of gut fungi and bacteria(before intervention)
- The species and genus abundance changes of fungi and bacteria gut microbiota composition(before and after 2, 12 weeks of intervention)
- Follicular stimulating hormone in serum(before and after 2, 12 weeks of intervention)
研究者
研究点 (1)
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