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临床试验/NCT02396264
NCT02396264Unknown不适用

Mediterranean Diet: A New Nutritional Approach for the Treatment of Normal Weight Women With Polycystic Ovary Syndrome (PCOS)?

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
improvement in insulin resistance measured by HOMA index

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized normocaloric Diet in normal weight women with PCOS.

详细描述

PCOS is the most common endocrine disorder of reproductive age women, that is often characterized by chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. In addition, although insulin resistance is a crucial pathogenetic factor for PCOS and lifestyle change program improves insulin resistance, no available data can also suggest whether non-obese women with PCOS benefit or did not from lifestyle change program including diet without calorie-restriction. Although there are not studies focused on the effectiveness and safety of Mediterranean diet in PCOS, several indirect studies performed in obese and/or insulin resistant subjects, seem to suggest a potential role of this diet in PCOS population and, in particular, on long-term PCOS-related health risk. In this study, the investigators' purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in normal weight women with 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

入排标准

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

入选标准

  • Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria), 18 ≤BMI ≤ 25

排除标准

  • Age <18 or >35 years, BMI less than 18 and higher than 25, Pregnancy, Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months, neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea).

结局指标

主要结局

improvement in insulin resistance measured by HOMA index

时间窗: 6 months

次要结局

  • improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio)(6 months)
  • improvment in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)(6 months)
  • improvement in metabolic parameters(total, LDL and HDL cholesterol)(6 months)

研究者

发起方
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Orio

prof

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

研究点 (2)

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