To Estimate the Prevalence of PCOS in Obese Premenopausal Women and Elucidate How They Respond to a Weight Reduction Treatment Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden.
研究概览
简要总结
Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS. Although it is well established that obesity increases the severity of the clinical features of PCOS, data regarding the prevalence of PCOS in obese women and the change in body weight in women with PCOS over time are scares. In a prevalence study it was investigated whether obesity increases the risk of PCOS in the general population and they demonstrated that the prevalence rate of PCOS in underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%, respectively, similar to that observed in the general population. These results suggest that the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in Spain.
First the investigators aim to estimate the prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard weight reduction regime to the same extent as women without PCOS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PCOS diagnostic criteria should be the presence of both clinical and/or biochemical hyperandrogenism and/or oligo-/amenorrhea and/or polycystic ovaries (PCO).
排除标准
- •Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
- •Pregnancy or breastfeeding the last 6 months.
- •Any sign of climacteric symptoms.
- •Language barrier or disabled person with reduced ability to understand information.
- •Oral contraceptives and insulin sensitizing agents is commonly used among women with PCOS since it may interfere with hormone profile. As the prevalence of PCOS can be assumed to be increased among women using oral contraceptives and insulin sensitizing agents, they are included but analyzed separately.
结局指标
主要结局
Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden.
时间窗: Within one month after first visit
Screening for PCOS among obese women includes menstrual history, clinical and biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound measure in women with one of signs included in the diagnosis of the syndrome.
次要结局
- Response to weight reduction regime among obese women with and without PCOS(One year after inclusion)
- Food frequency(Within one month after measure)
- Health Related Quality of Life(Screening and one year later)
- Symptoms of anxiety and depression(Screening and after one year)
- Changes in sex steroids and other related hormones(Screening and after 1 year)