Effectiveness of Bariatric Surgery for NAFLD/NASH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorBeijing Friendship Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age between 16 and 65 years (all sexes).
Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.
Diagnosed with hepatic steatosis preoperatively by radiologic (including ultrasonography, magnetic resonance imaging [MRI]-derived proton density fat fraction [PDFF]) or pathologic(intraoperative hepatic pathology) examinations.
Age between 16 and 65 years (all sexes).
Disqualifiers
any patient who had previously been submitted to any type of bariatric surgery;
history of excessive drinking: in the past 12 months, the male equivalent of alcohol consumption more than 30g/d, and the female more than 20g/d;
history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.；
history of specific diseases: Gene type 3 hepatitis C virus (HCV) infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of beta lipoproteinemia, congenital lipid atrophy, celiac disease which causing fatty liver, etc.;
Trial design
Treatments tested in this trial
- SG
- RYGB
- OAGB
Treatment groups
320 Participants
are divided into 3 treatment groupsSponsors and collaborators
Beijing Friendship Hospital
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Beijing Hospital (only for Base-NAFLD)
Collaborator
Beijing Shijitan Hospital, Capital Medical University
Collaborator
Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD)
Collaborator
Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD)
Collaborator
Beijing Chao Yang Hospital
Collaborator
Capital Medical University
Collaborator
The First Hospital of Kunming
Collaborator
Bishan Hospital of Chongqiang Medical University
Collaborator
The First Hospital of Hebei Medical University
Collaborator
Source ClinicalTrials.gov