Impact of Metabolic Disorders on cACLD Outcomes

This multicenter, prospective, cohort study is designed to investigate how metabolic disorders (such as obesity, diabetes, and high cholesterol) influence the progression of liver disease in patients with compensated advanced chronic liver disease (cACLD). Chronic liver disease often progresses silently for many years before serious complications like liver failure, cancer, or variceal bleeding develop. While it is known that metabolic problems can accelerate liver damage, current tools for predicting individual risk remain limited. This study aims to enroll approximately 4,307 adults with cACLD from six major medical centers across China. Participants will undergo regular follow-up every 3 to 6 months for up to 5 years, during which routine clinical assessments, non-invasive imaging (including MRI elastography), metabolic health indicators, and biological samples will be collected. No experimental treatments are provided; participants receive standard medical care as determined by their physicians. The primary goal is to determine whether metabolic abnormalities are linked to serious liver-related events including ascites, variceal bleeding, hepatic encephalopathy, liver cancer, liver failure, and liver-related death. The study will also evaluate how advanced imaging techniques predict these complications and develop a comprehensive risk prediction model integrating metabolic factors, imaging results, and traditional liver function tests. By better understanding the role of metabolic health in liver disease progression, this research may help identify new intervention targets and improve the ability to predict which patients are most likely to develop serious complications, ultimately leading to more personalized care and better outcomes for individuals with chronic liver disease.

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Key information

Conditions

Compensated Advanced Chronic Liver Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Voluntary signing of written informed consent;
Aged between 18 and 75 years (inclusive of 18 and 75), both genders eligible;
Evidence of liver cirrhosis by imaging (including ultrasonography, CT, MRI), or pathological findings indicating F3/4 fibrosis, or Liver Stiffness Measurement (LSM) ≥10 kPa as measured by VCTE;

Exclusion criteria

Decompensated cirrhosis at baseline, defined as having experienced any of the following three conditions within the past year: ① History of variceal bleeding; ② Moderate to severe ascites; ③ Overt hepatic encephalopathy;
Prior or current diagnosis of hepatocellular carcinoma or other malignancies that cannot be treated with curative intent, with an expected survival of less than 1 year;
Previous orthotopic liver transplantation;
Concurrent hematological and lymphatic system diseases;
Concurrent severe dysfunction of vital organs such as the heart, lungs, brain, and kidneys:

History of pulmonary diseases: Severe pulmonary diseases that significantly affect lung function, such as severe emphysema, pulmonary embolism;

History of severe heart disease, meeting one of the following criteria:

Decompensated cardiac insufficiency (New York Heart Association [NYHA] Class III-IV);
Unstable angina pectoris; Chronic Kidney Disease (CKD) stage ≥3 (defined as baseline serum creatinine exceeding 177 μmol/L);

Pregnant or breastfeeding women;
Judged by the investigator to be unsuitable for participation in this study.

Treatment and study plan

observational study

Other

This is a multicenter, prospective, observational cohort study. No study-specific interventions are administered. Participants receive standard medical care as determined by their treating physicians according to routine clinical practice. All examinations, including imaging and laboratory tests, are performed as part of standard care or for observational research purposes only, without assignment to a specific treatment arm.

Primary outcomes

Occurrence of liver-related adverse events.

Time frame: 5 years

Decompensation: clinically significant ascites, esophageal-gastric variceal bleeding, overt hepatic encephalopathy; Liver failure; Hepatocellular carcinoma.

Secondary outcomes

Liver-related death

Time frame: 5 years
Non-liver-related clinical events

Time frame: 5 years

Cardiovascular and cerebrovascular events, extrahepatic organ failure, extrahepatic malignancies, new-onset diabetes mellitus, fractures, chronic kidney disease
All-cause death

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

Impact of Metabolic Disorders on Clinical Outcomes in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Prospective, Cohort Study

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2031
First posted: Apr 16, 2026
Registry last updated: Apr 16, 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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Completed