NCT04366999 Effectiveness of Bariatric Surgery for NAFLD/NASH
| NCT ID | NCT04366999 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Friendship Hospital |
| Condition | Bariatric Surgery Candidate |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2020-04-21 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2020-04-21 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: \[For Base-NAFLD\] 1. Age between 16 and 65 years (all sexes). 2. 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. 3. 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. \[For Base-NASH\] 1. Age between 16 and 65 years (all sexes). 2. 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. 3. Histologically confirmed NASH with fibrosis: NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1 Exclusion Criteria: * 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.; * previous major gastrointestinal surgery； * diagnosed or suspected malignancy； * poorly controlled significant medical or psychiatric disorders； * disorders such as a medical history of major pathology; * can not be able to understand and willing to participate in this registry with signature.
Contact & Investigator
Zhongtao Zhang, M.D.;Ph.D.
PRINCIPAL INVESTIGATOR
Beijing Friendship Hospital
Frequently Asked Questions
Who can join the NCT04366999 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Bariatric Surgery Candidate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04366999 currently recruiting?
Yes, NCT04366999 is actively recruiting participants. Contact the research team at zhangzht@ccmu.edu.cn for enrollment information.
Where is the NCT04366999 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04366999 clinical trial?
NCT04366999 is sponsored by Beijing Friendship Hospital. The principal investigator is Zhongtao Zhang, M.D.;Ph.D. at Beijing Friendship Hospital. The trial plans to enroll 320 participants.