Efficacy of Bariatric & Metabolic Surgery for Metabolic associated Fatty Liver Disease (MAFLD) : A Prospective Clinical Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000035422

Enrollment

Unknown

Registered

2020-08-10

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-08-17

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

Group R:Roux-en-Y Gastric Bypass

Group S:Sleeve Gastrectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 16-65 years old; 2. Indications in line with the " Surgical Treatment for Obesity and Type 2 Diabetes: Chinese Guidelines (2019 Edition)"; 3. Imaging or pathological findings suggest liver steatosis (in accordance with any of the following 3 items): (1) Preoperative abdominal ultrasound indicates fatty liver; (2) Preoperative abdominal MRI indicates liver fat content >=5%; (3) Liver pathology suggests liver steatosis.

Exclusion criteria

Exclusion criteria: 1. Those who have previously undergone bariatric & metabolic surgery or major gastrointestinal surgery; 2. A history of excessive drinking: in the past 12 months, the alcohol equivalent of men's alcohol consumption is greater than 30g/d, and the female is greater than 20g/d; 3. A history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.; 4. Existence of genotype 3 hepatitis C virus (HCV) infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of ß lipoproteinemia, congenital lipid atrophy, celiac disease, etc. History of specific diseases of fatty liver; 5. Diagnosed or suspected of malignant tumor; 6. Hepatitis B virus infection, with HBsAg (+); 7. HIV infected; 8. Mental and neurological disorders, who cannot express their wishes correctly; 9. With other serious diseases that affect the evaluation of this study, who cannot 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

Measure	Time frame
Liver fat conten;	—

Secondary

Measure	Time frame
Weight;blood glucose;A1c;Serum Insulin;C-peptide;Serum Lipid;serum liver enzymology;AFP;	—

Countries

China

Contacts

Public ContactHongwei Zhang

Department of Metabolic & Bariatric Surgery, Shanghai Jiaotong University Affiliated Sixth People's Hospital

zhw00sub@163.com+86 13917135942

Outcome results

None listed

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