MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- MicroRNA profile
研究概览
简要总结
The aim of this study is to explore the microRNA profile in serum of women with Polycystic Ovary Syndrome and investigate the correlation between the microRNA profile and markers of metabolic syndrome.
详细描述
The study consist of 2 parts:
- A cross-sectional study of a cohort of women with PCOS with analysis of materials from the established biobank. (the PICOLO cohort) Data and blood samples from 266 women with PCOS was collected from January 2010 - February 2013 as a part of the PICOLO collaboration: "PCOS, infertility, Cardiovascular and Obstetric risk markers and Long-term Outcome" at Holbaek Fertility Clinic and at Herlev Hospital.
Serum samples will be analysed with Reverse Transcript polymerase chain Reaction (RT-qPCR) for selected microRNAs. 2. A follow-up study of local participants from the PICOLO study. 90 of the participants were recruited at Holbaek Fertility Clinic.
Following tests will be performed at reexamination, in order to describe the clinical phenotype: Health interview, anthropometrics, acne score, Ferriman-Gallway score, blood pressure, Transvaginal ultrasound of uterus and ovaries, insulin Resistance (IR) assessed with Oral glucose Tolerance test (OGTT), Venous blood for hormone analysis and lipid status.
MicroRNA analysis with Taqman microRNA array will be performed on serum samples.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 40 years when included in the PICOLO study
- •PCOS based on the Rotterdam 2003 consensus criteria
排除标准
- •Contraceptive pills within 8 weeks from examination,
- •endocrinological disease (i.e. type 1 diabetes thyroid dysfunction),
- •Severe endometriosis (stage III and IV)
- •Premature ovarian insufficiency,
- •Breastfeeding women and
- •Pregnancy.
结局指标
主要结局
MicroRNA profile
时间窗: MicroRNA analysis will be performed on serum from baseline visit (biobank material) and on serum obtained from a follow-up visit 5 years after baseline. The participants will be examined for 2 hours at follow up.
The change in relative expression of MicroRNA in women with PCOS will be assessed, using TaqMan microRNA arrays, comparing serum samples from baseline from an existing biobank with serum samples from a follow up visit.
次要结局
- Abdominal obesity(The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.)
- Overweight(The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.)
- Dyslipidemia(The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.)
- Blood Pressure(The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.)
- PCOS status(The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.)
- Insulin Resistance and Type 2 Diabetes(The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.)