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临床试验/NCT04365855
NCT04365855招募中不适用

The Olmsted NAFLD Epidemiology Study (TONES)

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2020年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
800
试验地点
1
主要终点
Prevalence of NAFLD and NASH in the population

研究概览

简要总结

Researchers are assessing the prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) in the population and assembling a well-characterized cohort of adults with NAFLD and NASH to validate models of NAFLD diagnosis and determine long-term outcomes.

详细描述

Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. Recent information on the prevalence of NAFLD in general and Non-Alcoholic Steatohepatitis (NASH) with fibrosis in particular is very scarce. Such information is crucial for defining the epidemiology of NAFLD, identifying risk factors for advanced fibrosis and longitudinal outcomes. This study will enroll a random sample of adults from Olmsted County, Minnesota, to validate machine learning models for NAFLD diagnosis and disease severity. These data would be fundamental for the development of screening strategies in the community, which are urgently needed for early diagnosis of liver fibrosis and therapeutic interventions before cirrhosis develops.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Olmsted County residents at the time of search
  • Age 18 or older
  • No personal history of NAFLD diagnosis (administrative codes)

排除标准

  • Alcohol in excess (more than 20 gm per week in women and 30 gm per week in men)
  • Currently pregnant
  • Have contraindications to MRI (MRI incompatible implanted devices, severe claustrophobia)

研究组 & 干预措施

Subjects at risk for NAFLD

Other

Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

干预措施: Magnetic Resonance Elastography (Diagnostic Test)

Subjects at risk for NAFLD

Other

Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

干预措施: Blood draw (Other)

Subjects at risk for NAFLD

Other

Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

干预措施: Liver biopsy (Procedure)

Subjects at risk for NAFLD

Other

Adult Olmsted County residents identified as at risk for NAFLD will receive Magnetic Resonance Imaging (MRE,) blood tests,and possible biopsy.

干预措施: Fibro Scan (Procedure)

结局指标

主要结局

Prevalence of NAFLD and NASH in the population

时间窗: 5 years

Number of subjects with NAFLD and NASH determined by the MRE

次要结局

  • Long-term health outcomes(5 years)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alina M. Allen

Principal Investigator

Mayo Clinic

研究点 (1)

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