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OpenTrials
Completed

NCT Number: NCT07433205

Study on Risk Factors and Prognosis of MASLD

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan University affiliated Chengdu Second People's Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Fibrosis progression (noninvasive)

    Time frame: 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).

  2. Composite liver-related clinical events

    Time frame: 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.

Secondary outcomes

  1. Steatosis change

    Time frame: Baseline to 2 years.

    Change in hepatic steatosis assessed by CAP (controlled attenuation parameter) and/or imaging (ultrasound/CT/MRI-PDFF if available).

  2. Liver enzymes improvement/worsening

    Time frame: Baseline to 2 years.

    Change in ALT and AST levels.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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