A cohort study of bariatric surgery in the treatment of moderate to severe obesity with non-alcoholic fatty liver disease (NAFLD)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036513

Enrollment

Unknown

Registered

2020-08-23

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

Non-alcoholic fatty liver disease

Interventions

LSG Group:laparoscopic sleeve gastrectomy

LRYGB Group:laparoscopic roux-en-Y gastric bypass

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chinese Han nationality aged 16-65 years; 2. Subjects with BMI >=30 kg/m2 and diagnosed as NAFLD; 3. NAFLD patients without systematic treatment; 4. The indications of bariatric surgery are in accordance with the relevant provisions of the 2019 Chinese guidelines for the diagnosis and treatment of obesity and type 2 diabetes mellitus; 5. The diagnosis of NAFLD is in accordance with the relevant provisions of the 2018 Chinese guidelines for the prevention and treatment of nonalcoholic fatty liver disease.

Exclusion criteria

Exclusion criteria: 1. Patients with drug abuse, alcohol addiction or uncontrollable mental illness; 2. Patients with mental retardation or immaturity and uncontrollable behavior; 3. The patients who did not meet the expectation of surgery; 4. Patients who are not willing to bear the potential risk of surgery; 5. Patients with poor general condition who can not tolerate general anesthesia; 6. Patients with a history of excessive drinking (alcohol consumption of no less than 210g per week for men and no less than 140g for women in the past 12 months) or taking drugs such as amiodarone, tamoxifen, methotrexate, glucocorticoid, or suffering from hepatitis B virus (HBV or HCV) infection, autoimmune hepatosis, hepatolenticular degeneration, total parenteral nutrition, congenital lipid atrophy, beta Hypolipidemia, etc Celiac disease can lead to fatty liver disease; 7. Patients with central nervous system and respiratory system injury and tumor not cured; 8. Patients with systemic diseases such as hypothyroidism that have not been cured or controlled; 9. Other special circumstances shall be specified by the enrolled doctors.

Design outcomes

Primary

Measure	Time frame
LSR;	—

Secondary

Measure	Time frame
Liver fibrosis grade;liver function;Blood lipids;Fasting blood glucose;Fasting insulin;Weight change;	—

Countries

China

Contacts

Public ContactChengcan Yang

The Ninth People's Hospital Affiliated to medical school of Shanghai Jiaotong University

magicycc@163.com+86 15821423382

Outcome results

None listed

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