Actively Recruiting
Effectiveness of Bariatric Surgery for NAFLD/NASH
Led by Beijing Friendship Hospital · Updated on 2024-05-14
320
Participants Needed
1
Research Sites
349 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery. This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH with fribrosis, to explore the differences in the effectiveness among sleeve gastrostomy \[SG\], Roux-en-Y gastric bypass \[RYGB\], or one anastomosis gastric bypass \[OAGB\], and to explore the independent effectiveness of bariatric surgery in histological remission of NAFLD/NASH. The first stage of the cohort was started in 2020, named Base-NAFLD; In May 2024, based on Base-NAFLD, we plan to continue established a secondary cohort, named Base-NASH.
CONDITIONS
Official Title
Effectiveness of Bariatric Surgery for NAFLD/NASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 65 years (all sexes)
- Diagnosed with obesity according to World Health Organization criteria for Asian populations
- Scheduled for a primary bariatric surgery at participating centers
- For Base-NAFLD: Diagnosed with hepatic steatosis before surgery by imaging or tissue examination
- For Base-NASH: Histologically confirmed NASH with fibrosis with NAFLD activity score ≥4 and fibrosis stage ≥F1
You will not qualify if you...
- Previously had any type of bariatric surgery
- History of excessive alcohol consumption in past 12 months (more than 30g/day for males, 20g/day for females)
- History of taking certain medications such as amiodarone, methotrexate, tamoxifen, glucocorticoids
- History of specific diseases including type 3 hepatitis C virus infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of beta lipoproteinemia, congenital lipid atrophy, celiac disease causing fatty liver
- Prior major gastrointestinal surgery
- Diagnosed or suspected cancer
- Poorly controlled significant medical or psychiatric disorders
- Other major medical pathologies
- Unable or unwilling to understand and participate with consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
Z
Zhongtao Zhang, M.D.;Ph.D.
CONTACT
M
Mengyi Li, M.D.;Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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