Development and clinical verification of PCR kit for combined detection of key gene polymorphisms in metabolic associated fatty liver disease

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200063519

Enrollment

Unknown

Registered

2022-09-09

Start date

2022-08-30

Completion date

Unknown

Last updated

2023-04-17

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

Study group and control group:None

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Study group: liver fibrosis group inclusion criteria 1. Accorded with MAFLD diagnostic criteria; 2. Ages 18-80 years old; 3. Pathologically diagnosed grade 1 and above liver fibrosis; 4. Or patients with liver cirrhosis and advanced liver fibrosis diagnosed by non-invasive diagnosis:patients with liver cirrhosis (compensated and decompensated) were diagnosed according to clinical criteria. The non-invasive diagnosis of advanced liver fibrosis conforms to one of the following three items: FIB-4 = 2.67 or NFS = 0.676 or liver elasticity >= 11Kpa measured by Fibroscan? (2 times, interval 3 months). Control group: MAFLD patients without hepatic fibrosis Inclusion criteria: 1. Accorded with MAFLD diagnostic criteria; 2. Ages 18-80 years old; 3. Normal liver function (ALT/AST lower than the upper limit of detection value); 4. Liver elasticity < 6 kPa; 5. FIB-4 < 1.3; 6. Or no liver fibrosis was found pathologically.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the study group and control group 1. Lack of necessary demographic indicators, anthropometric indicators, laboratory indicators, etc.; 2. Lack of necessary past history and drug use history; 3. Combined with other causes of liver diseases, such as HBV, HCV infection, autoimmune liver disease, and other diseases, and the history of heavy drinking (alcohol intake in men > 210g/day, women > 140g/day). Secondary steatosis of the liver is caused by drugs, such as tamoxifen, hormones, etc; 4. Complicated with other serious diseases, which may affect the nutritional status of the body, such as malignant tumors, severe heart, lung, kidney, and other organic diseases; 5. Refuse to sign an informed consent form.

Design outcomes

Primary

Measure	Time frame
Liver fibrosis (grade 1 or higher);	—

Secondary

Measure	Time frame
Grade of hepatic steatosis and score of steatohepatitis;Non-invasive index of liver fibrosis;	—

Countries

China

Contacts

Public ContactZhang Jing

Beijing You An Hospital, Capital Medical University

drzhangjing@163.com+86 13391859683

Outcome results

None listed

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