Skip to content

Clinical study of UDFF in quantitative diagnosis of liver steatosis in MAFLD patients

Clinical study of UDFF in quantitative diagnosis of liver steatosis in MAFLD patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076457
Enrollment
Unknown
Registered
2023-10-09
Start date
2023-10-10
Completion date
Unknown
Last updated
2023-10-16

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:The diagnostic results of MRI (MRI-PDFF)
Index test:1. The reliability of UDFF and auto-pSWE measurements
2. The diagnostic efficacy of UDFF in liver steatosis
3. The diagnostic efficacy of auto-pSWE in liver fibrosis

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the experimental group: 1. Adults aged 18 to 75; 2. There is MRI imaging evidence (PDFF>5%), and one of the following three conditions is combined: overweight/obesity, type 2 diabetes, and metabolic dysfunction. A. Overweight/obesity: Body mass index (BMI) = 24 kg/m ²; B. Type 2 diabetes: a. Patients newly diagnosed as diabetes: fasting blood glucose = 7.0 mmol/L, or blood glucose level at 2h after meal = 11.0 mmol/L or glycosylated hemoglobin (HbA1c) = 6.5%; b. Diabetes patients who have been diagnosed (whether or not they are taking medicine); C. Metabolic dysfunction: There are at least two risks of metabolic abnormalities: a. Waist circumference: male = 90cm or female = 80cm; b. Blood pressure = 130/85mmHg or receiving antihypertensive medication treatment; c. Blood triglycerides = 1.7mmol/L or receiving lipid-lowering medication treatment; d. Plasma high-density lipoprotein cholesterol: Male2mg/L; Inclusion criteria for the normal control group: Those with values less than 5% detected by MRI-PDFF and no significant abnormalities in liver related serum biochemical indicators.

Exclusion criteria

Exclusion criteria: Excluding patients with ascites, as shear waves cannot propagate through fluids; Excluding those with incomplete clinical data; Excluding those who cannot tolerate fasting for 6 hours and ultrasound examination; Exclude patients with severe cardiovascular, cerebrovascular, liver, kidney, immune system diseases, or serious illnesses who cannot cooperate; Excluding contraindications for magnetic resonance imaging examinations such as claustrophobia, metal implants, pacemakers, and artificial metal heart valves.

Design outcomes

Primary

MeasureTime frame
Ultrasound-derived fat fraction;Automatic point shear wave elastic imaging technology;intraclass correlation coeficient,Coefficient of Variation;Sensitivity,specificity,ROC curve;

Secondary

MeasureTime frame
Blood routine, biochemistry, glycated hemoglobin, liver fibrosis, and fasting insulin levels;True positive, true negative, false positive, false negative;

Countries

China

Contacts

Public ContactJia Li

Zhongda Hospital Affiliated to Southeast University

13951609892@163.com+86 139 5160 9892

Outcome results

None listed

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