Study on Risk Factors and Prognosis of MASLD

Risk Factors and Prognosis of Metabolic Dysfunction-Associated Steatotic Liver Disease

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

• Study Type: Observational
• Enrollment (Actual): 922

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan University affiliated Chengdu Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 20-90 years will be enrolled into a prospective observational cohort, including participants with MASLD and a comparison cohort without MASLD at baseline, recruited from the same source population. Participants will undergo standardized clinical assessment, laboratory testing, and noninvasive liver evaluation at baseline and during follow-up for up to 2 years to assess metabolic risk factors, MASLD progression, and clinical outcomes.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrosis progression (noninvasive)	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).	Baseline to 2 years.
Composite liver-related clinical events	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.	Baseline to 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steatosis change	Change in hepatic steatosis assessed by CAP (controlled attenuation parameter) and/or imaging (ultrasound/CT/MRI-PDFF if available).	Baseline to 2 years.
Liver enzymes improvement/worsening	Change in ALT and AST levels.	Baseline to 2 years.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: Xuesong Doctor, First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20260220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No