Impact of Metabolic Disorders on cACLD Outcomes

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Compensated Advanced Chronic Liver Disease
• Intervention / Treatment: Other: Observational Study

• Study Type: Observational
• Enrollment (Estimated): 4307

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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:

1. Decompensated cardiac insufficiency (New York Heart Association [NYHA] Class III-IV);

2. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of liver-related adverse events.	Decompensation: clinically significant ascites, esophageal-gastric variceal bleeding, overt hepatic encephalopathy; Liver failure; Hepatocellular carcinoma.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death		5 years
Liver-related death		5 years
Non-liver-related clinical events	Cardiovascular and cerebrovascular events, extrahepatic organ failure, extrahepatic malignancies, new-onset diabetes mellitus, fractures, chronic kidney disease	5 years

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: MRE; metabolic disorders; cACLD
• Additional Relevant MeSH Terms: Nutritional and Metabolic Diseases; Metabolic Diseases; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 2026-IIT-SL-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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