Risk Factors and Prognosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 922
- 试验地点
- 1
- 主要终点
- Fibrosis progression (noninvasive)
研究概览
简要总结
This longitudinal cohort study will enroll individuals with MASLD (and/or those at risk) and follow them over time to identify clinical and metabolic risk factors for disease progression and to evaluate predictors of long-term outcomes, including fibrosis progression and liver-related events, major cardiovascular events, and all-cause mortality.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 to 90 years at enrollment. Able and willing to provide written informed consent. Willing and able to comply with study assessments and follow-up for up to 2 years.
- •Availability of baseline clinical evaluation and laboratory tests required by the protocol.
- •For the MASLD cohort: Evidence of hepatic steatosis at baseline (e.g., imaging and/or noninvasive assessment) in the presence of metabolic dysfunction, consistent with contemporary MASLD criteria, and without alternative causes of steatosis per protocol.
- •For the Control cohort: No evidence of MASLD/ hepatic steatosis at baseline (based on available imaging and/or noninvasive assessment), recruited from the same source population.
排除标准
- •Significant alcohol consumption exceeding protocol-defined thresholds. Known chronic liver diseases other than MASLD (including but not limited to chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency).
- •History of hepatocellular carcinoma, liver transplantation, or other active malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ) that may interfere with follow-up.
- •Decompensated liver disease at baseline (e.g., ascites, variceal bleeding, hepatic encephalopathy) if not intended to be included per protocol.
- •Use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic corticosteroids, tamoxifen) within a protocol-defined period, if judged to be the primary cause of steatosis.
- •Pregnancy or breastfeeding at enrollment (if applicable to your protocol assessments).
- •Any serious medical condition or psychiatric disorder that, in the investigator's opinion, would make participation unsafe or interfere with study assessments or follow-up.
研究组 & 干预措施
Control
Participants without MASLD at baseline, serving as a comparison cohort. Individuals will be recruited from the same source population as the MASLD cohort and will undergo the same standardized baseline assessment and follow-up schedule, including clinical evaluation, laboratory testing, and noninvasive liver assessment as applicable. Participants will be followed for incident MASLD and longitudinal changes in metabolic risk factors and clinical outcomes during the study period.
MASLD
Participants with MASLD at baseline, defined according to contemporary clinical criteria based on evidence of hepatic steatosis in the presence of metabolic dysfunction and in the absence of alternative causes of steatosis as specified in the protocol. Participants will undergo standardized baseline assessment and longitudinal follow-up, including clinical evaluation, laboratory testing, and noninvasive liver assessment (e.g., transient elastography and/or other validated measures as available). Follow-up will evaluate MASLD progression (including worsening steatosis and/or fibrosis) and the occurrence of clinical outcomes, such as liver-related events and major cardiovascular events, as well as all-cause mortality.
结局指标
主要结局
Fibrosis progression (noninvasive)
时间窗: Baseline to 2 years.
Change in liver fibrosis stage/risk assessed by transient elastography (liver stiffness measurement, LSM) and/or validated fibrosis scores (e.g., FIB-4, NAFLD Fibrosis Score).
Composite liver-related clinical events
时间窗: Baseline to 2 years.
Incidence of liver-related events (composite), including hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), new diagnosis of cirrhosis, hepatocellular carcinoma, liver transplantation, or liver-related death.
次要结局
- Steatosis change(Baseline to 2 years.)
- Liver enzymes improvement/worsening(Baseline to 2 years.)
研究者
Xuesong Wen
Doctor
First Affiliated Hospital of Chongqing Medical University