Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Plasma insulin level
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, investigators applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Female aged 18- 45 years old
- •Normal weight BMI 18.5--24
- •Diagnosis of hyperandrogenism T>0.481ng/ml
- •The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus
- •No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit
排除标准
- •T level is within the normal range
- •Organ dysfunction
- •Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months
- •Confirmed diagnosis of diabetes
- •Are on a diet, use weight-affecting medications, or have experienced a weight change of >4.5kg within 3 months prior to the start of the study
- •Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc.
- •Combined psychiatric disorders and severe primary diseases
- •Allergy to the drug or components of this study
- •Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions
研究组 & 干预措施
Chiglitazar group
Chiglitazar, tablet, 32mg, taken orally once daily for 3 months
干预措施: Chiglitazar (Drug)
Metformin group
Metformin, tablet, 0.5g, taken orally twice daily for 3 months
干预措施: Metformin (Drug)
结局指标
主要结局
Plasma insulin level
时间窗: Three months
Changes in insulin level before and after treatment
次要结局
- Total testosterone(Three months)
- Sex hormone-binding globulin(Three months)
- Ratio of luteinizing hormone to follicular estrogen(Three months)
- BMI and WHtR(At baseline and at 12 weeks after randomization via a standardized protocol.)
研究者
Yining Yang
Principal Investigator
Shengjing Hospital