Impact of Metabolic Disorders on cACLD Outcomes

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

This study will enroll approximately 4,307 adults with compensated advanced chronic liver disease (cACLD) from six major medical centers across China. Eligible participants are males and females aged 18-75 years with: (1) imaging evidence of cirrhosis; (2) pathological findings of F3/4 fibrosis; or (3) liver stiffness measurement ≥10 kPa by VCTE. Patients are excluded if they have prior decompensation events (variceal bleeding, moderate-severe ascites, overt hepatic encephalopathy), hepatocellular carcinoma/other malignancies with life expectancy \<1 year, prior liver transplantation, severe organ dysfunction, or are pregnant/breastfeeding. All participants provide written informed consent and undergo regular follow-up every 3-6 months for up to 5 years. No study-specified interventions are administered; participants receive standard medical care as determined by their physicians.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Study

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Occurrence of liver-related adverse events.

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

Time frame
5 years

Secondary outcomes

1

Liver-related death

Time frame
5 years
2

Non-liver-related clinical events

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

Time frame
5 years
3

All-cause death

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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