NCT07146815已完成不适用
PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease
Ziekenhuis Oost-Limburg1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2022年11月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Prevalence of NAFLD
研究概览
简要总结
To study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults (i.e. older than 18 years of age)
- •The diagnosis of PCOS based on expert opinion (i.e. according to Rotterdam criteria)
- •Able to understand patients information concerning this study
- •Able to give written informed consent
排除标准
- •Excessive alcohol use: ≥ 2u (20g)/day for females
- •Exclusion of other causes of liver disease
- •Secondary causes of liver steatosis
- •Other causes of endocrinological disease
- •Diseases that might mimic PCOS
研究组 & 干预措施
PCOS group
Other
Screening of women with PCOS
干预措施: FibroScan (Diagnostic Test)
Control group
Other
Screening of women without PCOS
干预措施: FibroScan (Diagnostic Test)
Control group
Other
Screening of women without PCOS
干预措施: MRI PDFF (Diagnostic Test)
PCOS group
Other
Screening of women with PCOS
干预措施: MRI PDFF (Diagnostic Test)
结局指标
主要结局
Prevalence of NAFLD
时间窗: Baseline and at follow-up 1 year later.
To study the prevalence of NAFLD in a population diagnosed with PCOS measured with Controlled Attenuation Parameter (CAP)
Prevalence of NAFLD in PCOS
时间窗: Baseline
To measure the prevalence of NAFLD in women with PCOS using the MRI-PDFF technique.
次要结局
未报告次要终点
研究者
研究点 (1)
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