Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Metabolic profile
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.
详细描述
Polycystic Ovary Syndrome (PCOS)
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
盲法说明
The study is open label. No blindness for participant or investigator is used
入排标准
- 年龄范围
- 18 Years 至 38 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Polycystic Ovary Syndrome according to Rotterdam criteria,
- •BMI ≥ 27 Kg/m2
排除标准
- •Type 2 diabetes mellitus,
- •in treatment for polycystic ovary syndrome features
研究组 & 干预措施
Metformin
Metformin 850mg twice a day for six months
干预措施: Metformin (Drug)
Magnesium
Magnesium chloride 250mg daily for six months
干预措施: Magnesium (Dietary Supplement)
PUFA omega 3
Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) 1.1mg daily for six months
干预措施: PUFA (Dietary Supplement)
结局指标
主要结局
Metabolic profile
时间窗: Six months after intervention
Serum concentration of metabolic biomarkers (glucose, insulin, triglycerides, cholesterol, HDL, M and M/I value derived from a euglycemic clamp)
次要结局
- Hormonal profile(Six months after intervention)
研究者
Mardia Guadalupe Lopez Alarcon
Investigador titular B
Coordinación de Investigación en Salud, Mexico
