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

Ma Zhe

Status: Completed

Conditions: Fatty Liver Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06487325

YXLL-KY-2024(014)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

120 participants in 3 patient groups

Group S1

Description:

Liver biopsy showed mild fatty liver

Group S2

Description:

Liver biopsy showed moderate fatty liver

Group S3

Description:

Liver biopsy showed severe fatty liver