临床试验/NCT01574261

NCT01574261Unknown早期 1 期

Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Catholic University of the Sacred Heart1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2012年3月最近更新: 2012年4月10日

适应症

干预措施

试验速览

阶段: 早期 1 期
发起方: Catholic University of the Sacred Heart
入组人数: 70
试验地点: 1
主要终点: CD4+ CD28 null T-lymphocyte frequency

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Polycystic Ovary Syndrome
•Age >18 and <35

排除标准

•Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

研究组 & 干预措施

Inositol

Active Comparator

Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment

干预措施: Inositol (Drug)

Placebo

Placebo Comparator

Patients will be randomized to receive placebo for four months

干预措施: Placebo (Drug)

结局指标

主要结局

CD4+ CD28 null T-lymphocyte frequency

时间窗: five minutes

次要结局

insulinaemic area OGTT AUCi, lipid profile, androgen levels(120 minutes)

研究者

发起方

Catholic University of the Sacred Heart

申办方类型

Other

责任方

Principal Investigator

主要研究者

Rosanna Apa

Professor

Catholic University of the Sacred Heart

研究点 (1)

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