Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of D-Chiroinositol (DCI) and Increases Circulating DCI in Obese Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Renal Clearance of D-chiroinositol (DCI) at 12 Days
研究概览
简要总结
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Obese women with PCOS and normal women aged 18-40,
- •PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
- •Normal regular monthly periods, no clinical evidence of androgen excess,
- •All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements
排除标准
- •DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
研究组 & 干预措施
Normal subjects
Normal subjects given diazoxide
干预措施: diazoxide (Drug)
PCOS subjects
PCOS subjects given diazoxide
干预措施: diazoxide (Drug)
结局指标
主要结局
Renal Clearance of D-chiroinositol (DCI) at 12 Days
时间窗: 12 days
Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay
Level of Circulating D-chiro Inositol (DCI)
时间窗: 12 days
Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide
次要结局
未报告次要终点