A Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease

Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease in Obese Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06487325

Enrollment

120

Registered

2024-07-05

Start date

2023-04-29

Completion date

2024-05-01

Last updated

2024-07-05

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

Conditions

Fatty Liver Disease

Brief summary

Aims: To evaluate the diagnostic performance of ultrasound-derived fat fraction (UDFF) in assessing the degree of hepatic steatosis in an obese population, with liver biopsy as reference standard. Materials and methods: Obese individuals, who were found to have fatty liver by B-mode ultrasound and underwent UDFF measurement, along with liver biopsy results, were retrospectively selected from The First Affiliated Hospital of Shandong First Medical University.The inclusion criteria were as follows: (1) BMI over 30 kg/m²; (2) diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound; (3) serologic test results were available. The exclusion criteria include: (1) patients who have undergone liver resection or have liver space-occupying lesions; (2) pregnant women; (3) patients with incomplete medical history data.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* BMI over 30 kg/m² * diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound * serologic test results were available

Exclusion criteria

* patients who have undergone liver resection or have liver space-occupying lesions * pregnant women * patients with incomplete medical history data

Design outcomes

Primary

Measure	Time frame	Description
UDFF values	up to 1 year	During the examination, the DAX probe was positioned in the right intercostal space, and the UDFF mode was selected to place a fixed-size region of interest (ROI) vertically in the right lobe of the liver, 1.5 cm away from the liver capsule, avoiding the intrahepatic duct structure. Measurements were acquired after the patient maintained a calm breathing pattern, and the system automatically determined the shear wave velocity (Vs), elastic modulus (E), and UDFF values.

Secondary

Measure	Time frame	Description
SWE values	up to 1 year	The auto-SWE values were collected simultaneously when using UDFF mode, and the SWE and pSWE values were collected 10 times with 5C1 and DAX probes, respectively

Countries

China

Outcome results