NCT04494360已完成不适用
Study for the Identification of Participants With Liver Steatosis Who Carry Genetic Variants Associated With Nonalcoholic Fatty Liver Disease (NAFLD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 830
- 试验地点
- 3
- 主要终点
- Prevalence of Genetic Variants Associated with NAFLD
研究概览
简要总结
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormality based on medical history, physical exam, and 12-lead electrocardiogram (ECG) collected during Visit 1
- •Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or b.) Permanently sterile
- •Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of genetic variants associated with NAFLD
- •Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
排除标准
- •History or presence of drug abuse within the 2 years prior to Visit 1
- •Excessive use of alcohol within 2 years prior to the study
- •Body mass index greater than (>) 40 kilogram per meter square (kg/m^2)
- •Evidence of other active (acute or chronic) liver disease other than NAFLD/ Nonalcoholic steatohepatitis (NASH)
- •History of bariatric surgery or planning to undergo bariatric surgery within the next year
- •Inability to undergo magnetic resonance imaging (MRI)
结局指标
主要结局
Prevalence of Genetic Variants Associated with NAFLD
时间窗: Up to 8 weeks
Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated.
Liver Fat Content Estimated with Fibroscan
时间窗: Up to 8 weeks
Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (\>=) 310 decibels per minute (dB/m) (that is, liver fat \>= 10 percent \[%\]) will be estimated.
次要结局
- Liver Fibrosis Estimated with Fibroscan(Up to 8 weeks)
- Hepatic Fat Fraction(Up to 8 weeks)
研究者
研究点 (3)
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