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Massive study to uncover how obesity and diabetes speed up liver damage
NCT ID NCT07534046
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows over 4,300 adults with compensated advanced chronic liver disease to see how metabolic disorders like obesity, diabetes, and high cholesterol affect disease progression. Participants receive standard care and are monitored every 3 to 6 months for up to 5 years. No experimental treatments are given. The goal is to build a risk prediction model that could help personalize care and prevent serious complications like liver failure or cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to predict serious liver complications and identify new targets for treatment.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. Results may not apply to all populations, and the long follow-up may lead to dropouts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 4,307 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
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