Targeting Pathophysiologic Pathways in Polycystic Ovary Syndrome Using a Response to Metformin Phenotype
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy
研究概览
简要总结
The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.
详细描述
The investigators propose to use both targeted and non-targeted metabolomic approaches to identify pathways associated with metformin's effect on insulin sensitivity, weight, androgens and endothelial function. This project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets. This pilot project is intended to inform the development of hypothesis and specific aims for a future grant application to National Institutes of Health (NIH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) greater than or equal to 25
- •Polycystic Ovary Syndrome criteria of both oligomenorrhea (<9 menses per year) and androgen excess [clinical hirsutism (Ferriman-Gallway score >8 or severe acne) or elevated testosterone].
- •Taking no medications for the treatment of insulin resistance.
排除标准
- •Diagnosis of Cushing's syndrome
- •Untreated hypo/hyperthyroidism
- •Elevated prolactin
- •Congenital adrenal hyperplasia
- •Renal insufficiency (creatinine > 1.5)
- •Medications that can significantly affect endothelial function
- •Pregnancy
- •Breast Feeding
- •Taking oral contraceptives
- •Currently smoking
研究组 & 干预措施
Metformin
Metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
干预措施: Metformin (Drug)
Delayed Start Metformin
After baseline study visit, this arm will return after three months without metformin for a repeat of the baseline study visit prior to initiating metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy
时间窗: Baseline, 3 months
Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule.
次要结局
- Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy(baseline, 3 months)