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The value of UDFF in evaluating MAFLD: a multicenter clinical study

The value of UDFF in evaluating MAFLD: a multicenter clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069459
Enrollment
Unknown
Registered
2023-03-17
Start date
2023-03-17
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

metabolic-dysfunction-associated fatty liver disease

Interventions

Gold Standard:Pathology of liver biopsy or MRI-derived proton density fat fraction
Index test:Ultrasound derived fat fraction

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Chinese patients aged 18-85 years; 2. Patients with diffuse or uneven fatty liver in conventional ultrasound. 3. Accordance with the definition of MAFLD: A positive diagnosis of MAFLD are based on histological (biopsy), imaging or blood biomarker evidence of fat accumulation in the liver (hepatic steatosis) in addition to one of the following three criteria, namely overweight/obesity, presence of type 2 diabetes mellitus (T2DM), or evidence of metabolic dysregulation. The latter is defined by the presence of at least two metabolic risk abnormalities: (1) Waist circumference >= 90/80 cm in men and women; (2) Blood pressure >= 130/85 mmHg or specific drug treatment; (3) Plasma triglycerides >= 150 mg/dl (>= 1.70 mmol/L) or specific drug treatment; (4) Plasma HDL-cholesterol = 2.5; (7) Plasma high-sensitivity C-reactive protein level > 2 mg/L. 4. Patients who will conduct liver biopsy or MRI-PDFF to evaluate the grade of liver fat within one week of UDFF examination. 5. Patients without bleeding risk (Plate>= 50 x 10^9/L, IRN <= 1.5). 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: Patients with pregnancy.

Design outcomes

Primary

MeasureTime frame
ultrasound derived fat fraction (UDFF);

Secondary

MeasureTime frame
shear wave elastography (SWE);

Countries

China

Contacts

Public ContactHong Ding

Huashan Hospital, Fudan University

ding_hong@fudan.edu.cn+86 13651886013

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026