---
title: Mechanism of TIPS to Improve Sarcopenia
nct_id: NCT06794853
overall_status: RECRUITING
sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
study_type: OBSERVATIONAL
primary_condition: Sarcopenia
countries: Taiwan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06794853.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06794853"
ct_last_update_post_date: 2026-02-11
last_seen_at: "2026-05-12T06:25:30.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Mechanism of TIPS to Improve Sarcopenia

**Official Title:** Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia by Down-regulation of FGF21

**NCT ID:** [NCT06794853](https://clinicaltrials.gov/study/NCT06794853)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 132
- **Lead Sponsor:** Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- **Collaborators:** The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Henan University of Science and Technology
- **Conditions:** Sarcopenia, Mechanism, Cirrhosis
- **Start Date:** 2025-06-01
- **Completion Date:** 2027-12
- **CT.gov Last Update:** 2026-02-11

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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.)
```

## Arms

- **Sarcopenia** — Patients were diagnosed with sarcopenia on the basis of CT-quantified skeletal muscle mass index (SMI) during preoperative TIPS and postoperative follow-up. The European Association for the Study of the Liver clinical practice guidelines were used to determine the threshold value for sarcopenia, and SMI was calculated from the ratio of L3 cross-sectional area to height on CT images; those with \<50 cm²/m² in men and \<39 cm²/m² in women were diagnosed with sarcopenia. Patients with preoperative sarcopenia and 1-year postoperative sarcopenia who were still diagnosed with sarcopenia were in the sarcopenia group.
- **Non-sarcopenia** — Patients were diagnosed with sarcopenia on the basis of CT-quantified skeletal muscle mass index (SMI) during preoperative TIPS and postoperative follow-up. The European Association for the Study of the Liver clinical practice guidelines were used to determine the threshold value for sarcopenia, and SMI was calculated from the ratio of L3 cross-sectional area to height on CT images; those with \<50 cm²/m² in men and \<39 cm²/m² in women were diagnosed with sarcopenia. Patients with sarcopenia before TIPS and without sarcopenia 1 year after TIPS were considered the non-sarcopenia group.

## Interventions

- **Transjugular Intrahepatic Portosystemic Shunt** (PROCEDURE) — All patients were treated with Transjugular Intrahepatic Portosystemic Shunt (TIPS).

## Primary Outcomes

- **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)** _(time frame: 1 year)_ — This 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 Outcomes

- **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)** _(time frame: 1 year)_
- **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)** _(time frame: 1 year)_
- **Association between Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels and Overall Survival after Transjugular Intrahepatic Portosystemic Shunt (TIPS)** _(time frame: 1 year)_

## Locations (1)

- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Taiwan — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.union hospital, tongji medical college, huazhong university of science and technology|wuhan||taiwan` — added _(2026-05-12)_

---

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