Skip to content

Mechanism of TIPS to Improve Sarcopenia

Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia by Down-regulation of FGF21

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06794853
Enrollment
132
Registered
2025-01-27
Start date
2025-06-01
Completion date
2027-12-01
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia, Mechanism, Cirrhosis

Keywords

sarcopenia, cirrhosis, FGF21

Brief summary

Sarcopenia is particularly common in patients with chronic liver disease, especially in patients with decompensated cirrhosis, where the prevalence can be more than 50%. Sarcopenia is an important risk factor for a significant increase in mortality in cirrhotic patients, and is closely associated with a high incidence of complications such as hepatic encephalopathy, ascites, and infections . Recent studies have found that TIPS not only significantly improves clinical symptoms caused by portal hypertension, but may also have a positive effect on skeletal muscle mass and function in patients. Although the effect of TIPS in improving sarcopenia has been preliminarily confirmed, its mechanism is not yet fully understood. Therefore, there is an urgent need to explore the mechanism of action of TIPS to improve sarcopenia and provide guidance for clinical treatment options.

Detailed description

According to whether the sarcopenia improved or not in patients after TIPS, patients were divided into sarcopenia group and non-sarcopenia group, and the relationship between FGF21 levels and sarcopenia improvement in patients after TIPS was analyzed by analyzing the differences between the two groups. During the follow-up of patients after TIPS, blood samples were collected to test serum FGF21 levels and imaging examinations were performed to assess the improvement of sarcopenia; changes in nutritional status, muscle strength and function indicators were analyzed in the process of sarcopenia improvement; changes in serological indicators were analyzed in the process of sarcopenia improvement, with a focus on the serum FGF21 level; the combination of the serum FGF21 level and the muscle strength and function indicators, and evaluate their value in the prognosis of TIPS.

Interventions

All patients were treated with Transjugular Intrahepatic Portosystemic Shunt (TIPS).

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
The First Affiliated Hospital of Henan University of Science and Technology
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Pearson Correlation between Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels and Changes in Skeletal Muscle Index (SMI) at 1 Year after Transjugular Intrahepatic Portosystemic Shunt (TIPS)1 yearThis endpoint evaluates whether longitudinal changes in circulating FGF21 levels after TIPS have a significant Pearson correlation with changes in skeletal muscle mass. Skeletal muscle mass is quantified by the Skeletal Muscle Index (SMI), which is measured by abdominal Computed Tomography (CT) in the unit of cm²/m² . Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). This endpoint is intended to determine the role of FGF21 in TIPS-related improvement of sarcopenia.

Secondary

MeasureTime frameDescription
Pearson Correlation Analysis between Changes in Handgrip Strength and Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels after Transjugular Intrahepatic Portosystemic Shunt (TIPS)1 yearThis outcome measure focuses on the dynamic changes in skeletal muscle strength after TIPS, with handgrip strength as the sole assessment index, measured by an electronic handgrip dynamometer in the unit of kilogram-force (kgf). Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). Pearson correlation analysis was used to explore the linear correlation between the dynamic changes in handgrip strength and the dynamic changes in serum FGF21 levels after TIPS, so as to reflect the functional recovery status of skeletal muscle in the dimension of muscle strength.
Pearson Correlation Analysis between Changes in Gait Speed and Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels after Transjugular Intrahepatic Portosystemic Shunt (TIPS)1 yearThis outcome measure focuses on the dynamic changes in physical motor function after TIPS, with gait speed as the sole assessment index, measured by the 6-meter walk test in the unit of meter per second (m/s). Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). Pearson correlation analysis was used to explore the linear correlation between the dynamic changes in gait speed and the dynamic changes in serum FGF21 levels after TIPS, so as to reflect the functional recovery status of skeletal muscle in the dimension of physical performance.
Association between Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels and Overall Survival after Transjugular Intrahepatic Portosystemic Shunt (TIPS)1 yearThis endpoint investigates whether longitudinal dynamic changes in serum FGF21 levels have a significant association with the overall survival of patients after TIPS, so as to explore the prognostic value of serum FGF21 levels for the survival outcome of patients after TIPS. Cox proportional hazards regression model will be used to analyze the association between dynamic changes in serum FGF21 levels and overall survival, so as to determine whether dynamic changes in serum FGF21 levels are independent influencing factors of overall survival in patients after TIPS. Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). Overall survival is defined as the time from TIPS surgery to all-cause death or the last follow-up, assessed based on clinical follow-up records in the unit of month.

Countries

Taiwan

Contacts

CONTACTJiacheng Liu Dr.
1946046224@qq.com18627162379

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026