Skip to content

Derivation of a precise liver fat content assessment index in patients with non-alcoholic fatty liver disease

Derivation of a precise liver fat content assessment index in patients with non-alcoholic fatty liver disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096275
Enrollment
Unknown
Registered
2025-01-21
Start date
2024-11-13
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

non-alcoholic fatty liver

Interventions

Gold Standard:The pathological diagnosis is based on the gold standard. Non alcoholic fatty liver disease (NAFLD): Fatty changes characterized by large or predominantly large follicles involving more
The combination of significant liver fibrosis or interstitial fibrosis (F2-3) is fibrotic NASH. NAFLD related cirrhosis: Concomitant cirrhosis (F4) is NASH cirrhosis.
Index test:Histopathology of the liver Oil Red O Test HE-staining FIB-4 APRI NFS FLI VAI LAP CVAI

Sponsors

Kailuan General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1). Adults aged 18-75 years with suspected NAFLD and paired liver biopsy and serum samples (all obtained within 6 months); 2). Cognitively unimpaired and able to complete the questionnaire independently; 3). Ability to read, understand and give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Surgical contraindications exist; 2. There is a history of alcohol consumption: there is a long-term history of alcohol consumption, generally more than 5 years, equivalent to alcohol quantity >= 30g/d for men and >= 20g/d for women; Or a history of heavy drinking within 2 weeks, equivalent to ethanol volume > 80g/d; 3. There are hepatolenticular degeneration, hepatitis C, no ß-lipoproteinemia, Reye syndrome, HELLP syndrome, hereditary metabolic diseases and other possible causes of hepatic steatosis; 4. Oral vitamin E, pioglitazone, SLGT-2 inhibitors; Patients with subcutaneous injection of liraglutide, Semaglutide and intravenous injection of Tipotide injection; 5. Mental abnormality, cognitive dysfunction, unable to correctly express their wishes; 6. Diagnosed or suspected malignant tumor; Liver disease with other causes (diagnosed as viral hepatitis B or C infection, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease, autoimmune hepatitis, or HIV); 8. Severe coagulation dysfunction or thrombocytopenia; 9. There are other serious diseases that affect the evaluation of this study at the same time, and it is impossible to cooperate; 10. Those who cannot understand the procedures and methods of this clinical study, refuse to participate and refuse to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Liver fat content;

Secondary

MeasureTime frame
Aspartate aminotransferase; Alanine aminotransferase;Serum gamma-glutamyl transpeptidase;Total cholesterol;LDL cholesterol;HDL cholesterol;Triglycerides;Height;Weight;Abdominal (waist) measurement;Hip circumference;Blood pressure;Total Protein;Albumin;Platelet Count;Prothrombin Time ;Bilirubin;

Countries

China

Contacts

Public ContactMa Xiangming

Kailuan General Hospital

maxiangming@tmu.edu.cn+86 133 3315 8299

Outcome results

None listed

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