Bariatric Surgery CandidateNCT04366999
Effectiveness of Bariatric Surgery for NAFLD/NASH
An observational study of Bariatric Surgery Candidate and NAFLD, run by Beijing Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis
- What is being tested?
- SG, RYGB and OAGB
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
Who may be able to join
- [For Base-NAFLD]
- 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.
- [For Base-NASH]
- Age between 16 and 65 years (all sexes).
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- 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.
- Histologically confirmed NASH with fibrosis:
- NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Zhongtao Zhang, M.D.;Ph.D., +86-13801060364, zhangzht@ccmu.edu.cn
Zhongtao Zhang, M.D.;Ph.D.
About this study
Official title: Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
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
- Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis
- Being tested
- SG, RYGB, OAGB
- Keywords
- Bariatric surgery, NAFLD, NASH, Fibrosis, Obesity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGProcedure or surgery
SG involved a vertical gastric resection beginning 4-6 cm from the pylorus and ending 1-2 cm from the His angle, using linear staplers with the guidance of a 36 French intragastric bougie.
RYGBProcedure or surgery
RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
OAGBProcedure or surgery
OAGB entails the creation of a long gastric tube by beginning 2 cm below the angular incisure starting from the lesser curvature side and then divided vertically upward by linear cutting staplers as calibrated with a 36 French bougie, followed by the creation of a single gastrojejunal anastomosis with an afferent biliopancreatic limb of 200 cm.
| Study group | Role | What they receive |
|---|---|---|
| SG | In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure. Receives: Procedure: SG | |
| RYGB | In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure. Receives: Procedure: RYGB | |
| OAGB | In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure. Receives: Procedure: OAGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
the remisson rate of NAFLD (for Base-NAFLD cohort)
Percentage of liver fat content <5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery.
Visit : Post-op 12 months (±30 Days)
Measured: 1 years after surgery
Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)
*NASH resolution was defined as presence of a CRN inflammation score of 0 or 1 and no hepatocyte ballooning (score of 0).
**Worsening of fibrosis was defined as an increase of one stage or more on the NASH-CRN fibrosis score at 1-year follow-up.
Measured: 1 years after surgery
Secondary outcomes (5)
the rate of fibrosis improvement without NASH worsening
NASH worsening, was defined as an increase of ≥1 point in either the lobular inflammation score or the hepatocyte ballooning score.
Measured: 1 year after surgery
changes in NASH and liver fbrosis biopsy fndings
2．including the NAS (NAFLD activity score) and SAF scores (steatosis [S], activity [A], and fbrosis [F]) .
Measured: 1 year after surgery
changes in body weight
- percent excess weight loss (%EWL): %EWL=([initial weight] - [postoperative weight])/([initial weight] - [ideal weight]) (idealweight is defned as a body mass index [BMI] of 25 kg/m2 at each follow-up point)
- percentage of total weight loss (%TWL): %TWL=([initial weight] - [postoperative weight])/([initial weight])×100
Measured: 3 months, 6 months, and 1 year after surgery
resolution of obesity-related comorbidities
4．blood glucose levels, lipid levels, and liver enzyme levels.
Measured: 1 year after surgery
incidence of adverse health events
Including but not limited to bleeding, ulcer, intestinal obstruction etc.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start21 Apr 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Hospital (only for Base-NAFLD), Beijing Shijitan Hospital, Capital Medical University, Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD), Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD), Beijing Chao Yang Hospital, Capital Medical University, The First Hospital of Kunming, Bishan Hospital of Chongqiang Medical University, The First Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, M.D.;Ph.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366999
- Sponsor's protocol ID
- Base-NAFLD/NASH
- Status last verified
- May 2024
- First submitted
- 21 Apr 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tang B, Shen Q, Yuan J, Huang X, Shao Y, Zhu N, Guo H, Cao H, Wang H, Wang H, Li J, Liu J, Hua R, Zang Y. Bariatric surgery resolves MASH by enhancing MAT1A-dependent one-carbon metabolism. Nat Commun. 2026 Jul 22;17(1):8934. doi: 10.1038/s41467-026-75822-y.
PubMed 42637748Wei L, Li M, Zeng N, Liu Y, Bai R, Zhang N, Song J, Zhang P, Yao Q, Yang Z, Zhao X, Zhang Y, Zhang P, Zhang Z. Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study. BMC Surg. 2021 Jun 24;21(1):298. doi: 10.1186/s12893-021-01296-y.
PubMed 34167531
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
- ClinicalTrials.gov ID
- NCT04366999
- Acronym / sponsor ID
- Base-NAFLD/NASH
- Conditions
- Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis
- Keywords
- Bariatric surgery, NAFLD, NASH, Fibrosis, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Hospital (only for Base-NAFLD), Beijing Shijitan Hospital, Capital Medical University, Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD), Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD), Beijing Chao Yang Hospital, Capital Medical University, The First Hospital of Kunming, Bishan Hospital of Chongqiang Medical University, The First Hospital of Hebei Medical University
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SG | – | Procedure: SGIn this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure. |
| RYGB | – | Procedure: RYGBIn this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure. |
| OAGB | – | Procedure: OAGBIn this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
Key inclusion criteria (9 listed)
- [For Base-NAFLD]
- 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.
- [For Base-NASH]
Key exclusion criteria (9 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGSG involved a vertical gastric resection beginning 4-6 cm from the pylorus and ending 1-2 cm from the His angle, using linear staplers with the guidance of a 36 French intragastric bougie. | Procedure or surgery | SG |
| RYGBRYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb. | Procedure or surgery | RYGB |
| OAGBOAGB entails the creation of a long gastric tube by beginning 2 cm below the angular incisure starting from the lesser curvature side and then divided vertically upward by linear cutting staplers as calibrated with a 36 French bougie, followed by the creation of a single gastrojejunal anastomosis with an afferent biliopancreatic limb of 200 cm. | Procedure or surgery | OAGB |
Primary outcome
the remisson rate of NAFLD (for Base-NAFLD cohort)
Time frame: 1 years after surgery
Percentage of liver fat content <5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery. Visit : Post-op 12 months (±30 Days)
Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)
Time frame: 1 years after surgery
*NASH resolution was defined as presence of a CRN inflammation score of 0 or 1 and no hepatocyte ballooning (score of 0). **Worsening of fibrosis was defined as an increase of one stage or more on the NASH-CRN fibrosis score at 1-year follow-up.
5 secondary outcomes
the rate of fibrosis improvement without NASH worsening
Time frame: 1 year after surgery
changes in NASH and liver fbrosis biopsy fndings
Time frame: 1 year after surgery
changes in body weight
Time frame: 3 months, 6 months, and 1 year after surgery
resolution of obesity-related comorbidities
Time frame: 1 year after surgery
incidence of adverse health events
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 42637748Tang B, Shen Q, Yuan J, Huang X, Shao Y, Zhu N, Guo H, Cao H, Wang H, Wang H, Li J, Liu J, Hua R, Zang Y. Bariatric surgery resolves MASH by enhancing MAT1A-dependent one-carbon metabolism. Nat Commun. 2026 Jul 22;17(1):8934. doi: 10.1038/s41467-026-75822-y.
- Derived from this study: PubMed 34167531Wei L, Li M, Zeng N, Liu Y, Bai R, Zhang N, Song J, Zhang P, Yao Q, Yang Z, Zhao X, Zhang Y, Zhang P, Zhang Z. Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study. BMC Surg. 2021 Jun 24;21(1):298. doi: 10.1186/s12893-021-01296-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhongtao Zhang, M.D.;Ph.D. principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and NAFLD, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongtao Zhang, M.D.;Ph.D. (+86-13801060364, zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the remisson rate of NAFLD (for Base-NAFLD cohort) (time frame: 1 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366999, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.