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临床试验/NCT02521753
NCT02521753终止不适用

Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial

Coordinación de Investigación en Salud, Mexico1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Metformin 850mg twice a day for six months

干预措施: Metformin (Drug)

Magnesium

Experimental

Magnesium chloride 250mg daily for six months

干预措施: Magnesium (Dietary Supplement)

PUFA omega 3

Experimental

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

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mardia Guadalupe Lopez Alarcon

Investigador titular B

Coordinación de Investigación en Salud, Mexico

研究点 (1)

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