Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study.
Luyang Wei, Mengyi Li, Na Zeng...
https://pubmed.ncbi.nlm.nih.gov/34167531Actively Recruiting
Age: 16Years - 65Years
All Genders
ID04366999
Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis: A Prospective, Multicentric Cohort Study
Led by Beijing Friendship Hospital · Updated on 2024-05-14
320
Participants Needed
1
Research Sites
104 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
Researchers are studying obese patients who need bariatric surgery to assess how effective this surgery is for treating nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) with fibrosis. The study compares three types of bariatric surgery: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one anastomosis gastric bypass (OAGB). The goal is to understand the independent effects of these surgeries on improving liver disease and fibrosis. This is a prospective, multicenter cohort study that began in 2020 and includes a secondary cohort starting in 2024 based on the original group.
CONDITIONS
Brief Title
Effectiveness of Bariatric Surgery for NAFLD/NASH
Who Can Participate
Age: 16Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 16 and 65 years (all sexes)
- Diagnosed with obesity according to WHO criteria for Asian populations
- Scheduled for a primary bariatric surgery at participating centers
- Diagnosed with hepatic steatosis by imaging or intraoperative liver pathology for Base-NAFLD cohort
- Histologically confirmed NASH with fibrosis (NAS 24 and fibrosis stage 1) for Base-NASH cohort
You will not qualify if you...
- Previous bariatric surgery of any type
- Excessive alcohol use in past 12 months (men >30g/day, women >20g/day)
- History of taking certain medications such as amiodarone, methotrexate, tamoxifen, glucocorticoids
- Specific diseases including type 3 hepatitis C infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, beta lipoproteinemia, congenital lipid atrophy, celiac disease causing fatty liver
- Previous major gastrointestinal surgery
- Diagnosed or suspected cancer
- Poorly controlled significant medical or psychiatric disorders
- Major pathological disorders
- Unable or unwilling to understand and consent to participate in the registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo one of three bariatric surgeries: sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB), followed by immediate post-operative care.
1 surgical visit with immediate post-operative care
Post-operative Follow-up
Duration - 1 year after surgery
Participants are monitored for changes in body weight, liver condition, and resolution of obesity-related comorbidities following surgery.
Visits at 3 months, 6 months, and 1 year after surgery
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Loading map...
Research Team
Z
Zhongtao Zhang, M.D.;Ph.D.
M
Mengyi Li, M.D.;Ph.D.
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here