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Non-invasive evaluation of nonalcoholic fatty liver disease (NAFLD) in obese patients

Non-invasive evaluation of nonalcoholic fatty liver disease (NAFLD) in obese patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068258
Enrollment
Unknown
Registered
2023-02-13
Start date
2023-02-13
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

nonalcoholic fatty liver disease

Interventions

Gold Standard:Histopathology of the liver
Index test:Elastic ultrasound, serological indicators of glucose and lipid metabolism, a2 macroglobulin, hyaluronic acid, CK-18

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-65 years old, gender is not limited; 2. Comply with the indications for bariatric surgery in the "Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes in China (2019 Edition)" and plan to undergo bariatric surgery; 3. Previous or preoperative physical examination, laboratory tests, and imaging examinations suggest fatty liver.

Exclusion criteria

Exclusion criteria: 1. There are surgical contraindications; 2. Alcohol drinking history: long-term drinking history, generally more than 5 years, the equivalent ethanol amount is >= 30 g/d for men and >= 20 g/d for women; or has a history of heavy drinking within 2 weeks, and the equivalent ethanol amount > 80 g/d; 3. Hepatolenticular degeneration, hepatitis C, abeta lipoproteinemia, Reye syndrome, HELLP syndrome, inherited metabolic diseases and other possible causes of hepatic steatosis; 4. Taking amiodarone, methotrexate, tamoxifen, glucocorticoids, sodium valproate, HIV antiretroviral drugs; 5. People with mental disorders, cognitive dysfunction, and those who cannot express their wishes correctly; 6. Diagnosed or suspected malignant tumors; 7. People with hepatitis B virus and hepatitis C virus infection; 8. HIV-infected persons; 9. Severe coagulation dysfunction or thrombocytopenia; 10. There are other serious diseases that affect the evaluation of this study at the same time, and those who cannot cooperate; 11. Cannot understand the procedures and methods of this clinical study, refuse to participate and refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
nonalcoholic fatty liver activity score;

Secondary

MeasureTime frame
Stages of liver fibrosis;

Countries

China

Contacts

Public ContactQiyuan Yao

Huashan Hospital, Fudan University

hs_cbms@sina.cn+86 21 5288 7788

Outcome results

None listed

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