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

NCT ID: NCT06487325

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-29

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group S1

Liver biopsy showed mild fatty liver

No interventions assigned to this group

Group S2

Liver biopsy showed moderate fatty liver

No interventions assigned to this group

Group S3

Liver biopsy showed severe fatty liver

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ma Zhe

OTHER

Sponsor Role lead

Responsible Party

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Ma Zhe

Director of Ultrasound

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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QianfoshanH

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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YXLL-KY-2024(014)

Identifier Type: -

Identifier Source: org_study_id

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