Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Body mass index
研究概览
简要总结
Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia, hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel glucose-lowering medication, have been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events in individuals with diabetes mellitus. However, evidences related to its management in non-diabetic PCOS women are limited. Hence, we want to give canangliflozin combined with metformin to women with PCOS to see its effect 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;
- •Diagnosed criteria meet the Rotterdam criteria (2003);
- •Insulin Resistance
排除标准
- •Women who are pregnant or have a pregnancy plan within six months;
- •Confirmed diagnosis of diabetes.
- •Congenital adrenocortical hyperplasia;
- •Hyperprolactinemia;
- •Hyperthyroidism or hypothyroidism;
- •Combined with liver or kidney diseases;
- •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 metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.
研究组 & 干预措施
Experimental: Canagliflozin/metformin group
Intervention with canagliflozin combined with metformin for three months
干预措施: Canagliflozin combined with metformin (Drug)
Active Comparator: Metformin group
Intervention with metformin for three months
干预措施: metformin (Drug)
结局指标
主要结局
Body mass index
时间窗: Three months
Changes in body mass index (BMI)
次要结局
- Dehydroepiandrosterone sulfate(Three months)
- Sex hormone-binding globulin(Three months)
- Androstenedione(Three months)
- Total testosterone(Three months)
研究者
Bing He
Professor Bing He
Shengjing Hospital