How TIPS may improve muscle loss in cirrhosis and the role of FGF21
Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia by Down-regulation of FGF21
This project tests whether TIPS helps people with cirrhosis regain muscle and whether blood FGF21 levels explain that improvement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT06794853 on ClinicalTrials.gov |
What this trial studies
Adults with cirrhosis undergoing TIPS will be followed and divided into groups based on whether their sarcopenia improves after the procedure. Blood samples will be collected over time to measure serum FGF21 while imaging and functional tests will track muscle mass, strength, and performance. The study will compare changes in FGF21 and clinical muscle measures between patients who improve and those who do not. The combined value of FGF21 and muscle function indicators will be analyzed for predicting outcomes after TIPS.
Who should consider this trial
Good fit: Adults aged 18–80 with diagnosed liver cirrhosis who are scheduled for TIPS and can give informed consent are ideal candidates.
Not a fit: Patients with active malignancy, recent major surgery or trauma, serious cardiovascular/cerebrovascular disease, cognitive impairment, or on certain immune‑suppressing treatments are excluded and may not benefit from the findings.
Why it matters
Potential benefit: If successful, the study could identify a blood marker and mechanism linking TIPS to muscle recovery, helping clinicians predict who will benefit and tailor post‑TIPS care.
How similar studies have performed: Previous clinical reports have shown TIPS can improve muscle mass and function in some cirrhotic patients, but the mechanism and the role of biomarkers like FGF21 remain largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with liver cirrhosis and needing TIPS surgical treatment; 2. Aged between 18-80 years old; 3. Able to understand and sign the informed consent form and willing to cooperate in completing the examinations and follow-up visits. Exclusion Criteria: 1. Combination of serious cardiovascular and cerebrovascular diseases (such as acute myocardial infarction, severe heart failure, etc.); 2. Suffering from malignant tumors and in the active stage; 3. Recent (within 3 months) history of major surgeries or traumas; 4. The presence of mental illness or cognitive disorders, which are unable to cooperate with the study; 5. Undergoing other special treatments that may affect the results of the study (such as certain specific immune-suppressing agents, hormones, etc.)
Where this trial is running
Wuhan
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jiacheng Liu Dr.
- Email: 1946046224@qq.com
- Phone: 18627162379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.