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Effectiveness of Bariatric Surgery for NAFLD/NASH | Clinical Trials | Clareo Health

RECRUITING

Effectiveness of Bariatric Surgery for NAFLD/NASH

Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study

NCT04366999•Beijing Friendship Hospital

View on ClinicalTrials.gov

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

Age

16 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 21, 2020

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2026

Last Updated

May 14, 2024

Enrollment

320

ESTIMATED participants

Conditions

Bariatric Surgery CandidateNAFLDNASH With Fibrosis

Interventions

PROCEDURE

RYGB

PROCEDURE

OAGB

PROCEDURE

Contacts

Zhongtao Zhang, M.D.;Ph.D.

CONTACT

+86-13801060364 zhangzht@ccmu.edu.cn

Mengyi Li, M.D.;Ph.D.

CONTACT

+86-15810993198 limengyi@ccmu.edu.cn

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NCT06215716

NASH With FibrosisMASH With Fibrosis

View study

RECRUITINGNA

Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery

NCT05695040

Bariatric Surgery Candidate

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effectiveness of Bariatric Surgery for NAFLD/NASH

Inclusion Criteria

Exclusion Criteria

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery

Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients