Skip to content

Prospective multicenter study on the assessment of metabolic associated fatty liver disease using ultrasound multi parameters combined with clinical indicators

Prospective multicenter study on the assessment of metabolic associated fatty liver disease using ultrasound multi parameters combined with clinical indicators

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090092
Enrollment
Unknown
Registered
2024-09-24
Start date
2023-07-05
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Metabolic associated fatty liver disease

Interventions

Gold Standard:MR Proton Density Fat Fraction (MR-PDFF)
Index test:USAT, Ultrasonic Attenuation, HepatoRenal Index (HRI) based on the original data of acoustic attenuation imaging, LTI, Texture Index based on acoustic attenuation imaging, and BMI, waist ci

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: ? Chinese citizens aged = 18 and = 60. ? Meets MAFLD diagnostic criteria: In adults with hepatic steatosis (detected either by imaging techniques, blood biomarkers/scores, or liver histology), these three groups are classified as MAFLD, namely overweight/obesity (BMI = 23 kg/m2), type 2 diabetes (T2DM) or metabolic disorder. The presence of at least two of the following metabolic risk abnormalities: • Waist circumference =90/80 cm in men and women • Blood pressure =130/85 mmHg or specific drug treatment • Plasma triglycerides =150 mg/dL (=1.70 mmol/L) or specific drug treatment • Plasma HDL-cholesterol 2 mg/L ? The patient agrees and voluntarily joins this study and signs an informed consent form. ? The patient has completed MR-PDFF examination according to clinical needs, and the examination is within 1 week of enrollment time.

Exclusion criteria

Exclusion criteria: ? Pregnant. ? Patients undergoing systemic chemotherapy or biological therapy, or patients after TACE surgery; Patients with tumors in the liver lobe segments to be sampled. ? The course of diabetes patients is more than 2 years or has a history of kidney disease.

Design outcomes

Primary

MeasureTime frame
Ultrasound Attenuation;Area under ROC curve;

Secondary

MeasureTime frame
HepatoRenal Index;Texture Index;

Countries

China

Contacts

Public ContactJie Ren

The Third Affiliated Hospital of Sun Yat-Sen University

renjieguangzhou@126.com+86 139 2515 5583

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026