Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity

NCT ID: NCT06720766

Last Updated: 2024-12-06

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

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-24

Study Completion Date

2025-03-31

Brief Summary

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The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.

The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.

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

PROSPECTIVE

Interventions

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FibbroScan and biopsy

In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18 years or older who provided written informed consent
2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
3. Patients who schedule to undergo FibroScan examination

Exclusion Criteria

1. Patients with ascites or pregnant women
2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)
3. Patients who have undergone liver transplantation
4. Patients with cardiac failure and/or significant valvular disease
5. Patients with haemochromatosis
6. Patients who have refused to undergo LB or blood tests
7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease
8. Patients participating in another clinical trial within the preceding 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third People's Hospital of Chengdu

OTHER

Sponsor Role lead

Responsible Party

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Hongmei Zhu

Assistant Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peisen Guo

Role: CONTACT

Phone: +8615803838681

Email: [email protected]

Facility Contacts

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Jiahui Yu

Role: primary

Other Identifiers

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CSY-YNXM-2023-001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-S-177

Identifier Type: -

Identifier Source: org_study_id