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Metabolic Disorders Accelerate cACLD Progression in 4,307 Adults

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Summary

ClinicalTrials.gov registered NIH observational cohort study NCT07534046 investigating how metabolic disorders (obesity, diabetes, high cholesterol) influence progression of compensated advanced chronic liver disease (cACLD) in approximately 4,307 adults. The multicenter study across six centers in China will follow participants every 3-6 months for up to 5 years collecting clinical assessments, MRI elastography imaging, metabolic indicators, and biological samples. No experimental treatments are administered; participants receive standard care.

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What changed

This study registration documents an NIH/ClinicalTrials.gov observational cohort study investigating metabolic disorders impact on compensated advanced chronic liver disease (cACLD) progression. The study will enroll 4,307 adults across six medical centers in China and follow them for up to 5 years with regular assessments including MRI elastography and metabolic health indicators. No new regulatory requirements or compliance obligations are established.

Healthcare providers and clinical researchers monitoring liver disease research should note this registration for awareness. The study aims to develop risk prediction models integrating metabolic factors, imaging, and liver function tests to better predict serious liver-related events including ascites, variceal bleeding, hepatic encephalopathy, liver cancer, liver failure, and liver-related death.

Archived snapshot

Apr 16, 2026

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Impact of Metabolic Disorders on cACLD Outcomes

Observational NCT07534046 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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 ...

Conditions: Compensated Advanced Chronic Liver Disease

Interventions: Observational Study

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534046

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical research Observational studies
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Pharmaceuticals

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