NAFLDFONSNCT05499949
The Franciscus Obesity NASH Study
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- What is being tested?
- NASH screening, Cardiac dysfunction screening and Liver biopsy
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 Sep 2029
- How long will I take part?
- 5 Years
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with morbid obesity enrolled for bariatric surgery at the Franciscus Gasthuis, Rotterdam, the Netherlands.
Who may be able to join
- Participants must fulfil all of the inclusion criteria (unless otherwise specified) for enrolment in the study.
- Participants must fulfil the criteria of the International Federation for the Surgery of Obesity (IFSO) at screening.
- Participants must be able to understand the nature of the study and written informed consent must be obtained before any study specific interventions are performed.
- The cardiac function of a subset group of 30 subjects aged 35 years and older with low transient elastography measurements (≤F1) and no known cardiac disease, hypertension or diabetes mellitus will be compared with a similar number of patients with high transient elastography measurements (≥F3) and no known cardiac disease, hypertension or diabetes mellitus. These patients will be consecutively included.
- The investigators will perform a liver biopsy during endoscopic bariatric surgery in the patients with an elevated transient elastography measurement (≥F2; suggesting fibrosis and therefore the presence of NASH) in order to correlate the histological diagnosis to the clinical diagnosis based on elastography. In those patients in whom the diagnosis of NASH is confirmed by histology, more detailed follow up in a separate program at the department of gastroenterology is indicated according to the current guidelines.
Who cannot join
- Patients who meet any of the following criteria at screening (unless otherwise specified) will be excluded from the study:
- Participants younger than 18 years or older than 65 years
- Participants with an established diagnosis of liver pathology like, but not limited to:
- Hepatitis B
- Hepatitis C
- Autoimmune hepatitis
Show all 16Show fewer
- Wilson's disease
- Hemochromatosis
- Primary biliary cholangitis
- Primary sclerosing cholangitis
- Alcoholic liver disease
- Histologically documented liver cirrhosis (fibrosis stage F4), at screening or in a historical biopsy.
- Participants with active HIV infection and/or treatment.
- Participants with diagnosed malignancies with or without active treatment.
- Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study.
- The participant does not understand Dutch.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after bariatric surgery.
In addition, genomics, microbiome and metabolomics analyses will be carried out.
Read the detailed description
After being informed about the study and potential risks, 300 eligible patients will be included.
All participants will undergo lifestyle intervention before bariatric surgery. Extensive cardiometabolic analyses will be carried out. At 5 different moments (twice before and 3 times after bariatric surgery), liver steatosis and elasticity will be evaluate using Fibroscan. For those with an elevated liver fibrosis measurement (TE ≥7.2 kilopascal with M probe or ≥7.95 kilopascal with extra large probe), a laparoscopic liver biopsy will be performed during surgery. Patients will undergo gastric sleeve resection, Roux-n-Y gastric bypass or gastric minibypass.
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- Being tested
- NASH screening, Cardiac dysfunction screening, Liver biopsy
- Keywords
- Transient elastography, Bariatric surgery
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASH screeningDiagnostic test
Evaluate liver steatosis and elasticity using transient elastography in the FONS group
Cardiac dysfunction screeningDiagnostic test
Evaluate cardiac dysfunction in 60 patients from the FONS group with transthoracic echocardiography
Liver biopsyDiagnostic test
For participants from the FONS group with an elevated liver fibrosis measurement (≥F2) with TE, a laparoscopic liver biopsy will be performed during the bariatric procedure.
| Study group | Role | What they receive |
|---|---|---|
| FONS group | Patients with morbid obesity enrolled for bariatric surgery in the Franciscus Gasthuis, Rotterdam, the Netherland Receives: Diagnostic Test: NASH screening; Diagnostic Test: Cardiac dysfunction screening; Diagnostic Test: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver steatosis
Measured: baseline (enrolment) and 5 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) 5 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver fibrosis
Measured: baseline (enrolment) and 5 years after bariatric surgery
Secondary outcomes (18)
Change from baseline in liver steatosis (in decibel/meter) after lifestyle intervention
Transient elastography is a non invasive test evaluating liver steatosis
Measured: baseline (enrolment) and 3 months later
Change from baseline in liver fibrosis (in kilopascal) after lifestyle intervention
Transient elastography is a non invasive test evaluating liver fibrosis
Measured: baseline (enrolment) and 3 months later
Change from baseline in liver steatosis (in decibel/meter) 1 year after bariatric surgery
Transient elastography is a non invasive test evaluating liver steatosis
Measured: baseline (enrolment) and 1 year after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) 1 year after bariatric surgery
Transient elastography is a non invasive test evaluating liver fibrosis
Measured: baseline (enrolment) and 1 year after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) 3 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver steatosis
Measured: baseline (enrolment) and 3 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) 3 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver fibrosis
Measured: baseline (enrolment) and 3 years after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) according to the type of bariatric surgery
To evaluate if the type of bariatric surgery (gastric sleeve resection, Roux-en-Y Gastric bypass, Gastric minibypass) influences the steatosis in patients with morbid obesity, measured 1 and 3 years after bariatric surgery, adjusted for baseline steatosis/elasticity.
Measured: baseline and 1 and 3 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) according to the type of bariatric surgery
To evaluate if the type of bariatric surgery (gastric sleeve resection, Roux-en-Y Gastric bypass, Gastric minibypass) influences the elasticity in patients with morbid obesity, measured 1 and 3 years after bariatric surgery, adjusted for baseline steatosis/elasticity.
Measured: baseline and 1 and 3 years after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) according to the genetic profile
To determine if candidate genetic markers (PNPLA3, TM6SF2, MBOAT7, GCKR and HSD17B13) are associated to changes in NAFLD/NASH severity in patients with morbid obesity one year after bariatric surgery.
Measured: baseline and 1 year after surgery
Change from baseline in liver fibrosis (in kilopascal) according to the genetic profile
To determine if candidate genetic markers (PNPLA3, TM6SF2, MBOAT7, GCKR and HSD17B13) are associated to changes in NAFLD/NASH severity in patients with morbid obesity one year after bariatric surgery.
Measured: baseline and 1 year after surgery
Change from baseline in liver steatosis (in decibel/meter) according to gender and ethnicities
To determine if liver steatosis differs between gender or ethnicities before bariatric surgery and the changes 1, 3 and 5 years after bariatric surgery
Measured: baseline and 1, 3 and 5 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) according to gender and ethnicities
To determine if liver elasticity differs between gender or ethnicities before bariatric surgery and the changes 1, 3 and 5 years after bariatric surgery
Measured: baseline and 1, 3 and 5 years after bariatric surgery
Change from baseline in liver steatosis liver steatosis (in decibel/meter) according to the gut microbiota
To investigate the change in the ratio of Firmicutes/Bacteroides in the distal gut microbiota in patients with morbid obesity with NAFLD/NASH 1 year after bariatric surgery and the effects of these changes on transient elastography measurements.
Measured: baseline and 1 year after bariatric surgery
Change from baseline in liver steatosis liver fibrosis (in kilopascal) according to the gut microbiota
To investigate the change in the ratio of Firmicutes/Bacteroides in the distal gut microbiota in patients with morbid obesity with NAFLD/NASH 1 year after bariatric surgery and the effects of these changes on transient elastography measurements.
Measured: baseline and 1 year after bariatric surgery
Association between NAFLD/NASH and vascular dysfunction
To determine if the presence of NAFLD/NASH before bariatric surgery is associated with (subclinical) vascular dysfunction using the carotid intima media thickness and pulse wave velocity
Measured: baseline
Association between NAFLD/NASH and cardiac dysfunction
To determine if the presence of NAFLD/NASH before bariatric surgery is associated with (subclinical) cardiac dysfunction using transthoracic echocardiography
Measured: baseline and 1 year after bariatric surgery
Association between change in NAFLD/NASH and change in cardiac dysfunction
To determine if change of liver fibrosis stage is associated to change in cardiac function 1 year after bariatric surgery
Measured: baseline and 1 year after bariatric surgery
Correlation between histology and transient elastography measurement in a population with morbid obesity
To establish the correlation between histology (liver biopsy) and transient elastography measurement in a population with morbid obesity
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, Erasmus Medical Center, Leiden University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499949
- Sponsor's protocol ID
- FONS
- Acronym
- FONS
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2022
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon reasonable request. The data that will be shared is individual participant data that underlie the results reported in the study, after deidentification (text, tables, figures and appendices). Also, the study protocol will be available. Data will be available beginning 9 months and ending 36 months following publication, for researchers who provide a methodologically sound proposal for any purpose. Proposals may be directed to w.theel@franciscus. nl up to 36 months following article publication. After 36 months, the data will be available in our hospital's data warehouse but without investigator support other than deposited metadata.
Publications
Theel WB, Boxma-de Klerk BM, Dirksmeier-Harinck F, van Rossum EF, Kanhai DA, Apers JA, van Dalen BM, De Knegt RJ, Neecke B, van der Zwan EM, Grobbee DE, Hankemeier T, Wiebolt J, Castro Cabezas M. Effect of bariatric surgery on NAFLD/NASH: a single-centre observational prospective cohort study. BMJ Open. 2023 Jul 3;13(7):e070431. doi: 10.1136/bmjopen-2022-070431.
PubMed 37400234
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Franciscus Obesity NASH Study
- ClinicalTrials.gov ID
- NCT05499949
- Acronym / sponsor ID
- FONS / FONS
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- Keywords
- Transient elastography, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Collaborators
- Amsterdam UMC, Erasmus Medical Center, Leiden University Medical Center
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 12 Aug 2022 (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.
The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after bariatric surgery.
In addition, genomics, microbiome and metabolomics analyses will be carried out.
Detailed description
After being informed about the study and potential risks, 300 eligible patients will be included.
All participants will undergo lifestyle intervention before bariatric surgery. Extensive cardiometabolic analyses will be carried out. At 5 different moments (twice before and 3 times after bariatric surgery), liver steatosis and elasticity will be evaluate using Fibroscan. For those with an elevated liver fibrosis measurement (TE ≥7.2 kilopascal with M probe or ≥7.95 kilopascal with extra large probe), a laparoscopic liver biopsy will be performed during surgery. Patients will undergo gastric sleeve resection, Roux-n-Y gastric bypass or gastric minibypass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FONS group | – | Diagnostic Test: NASH screening, Diagnostic Test: Cardiac dysfunction screening, Diagnostic Test: Liver biopsyPatients with morbid obesity enrolled for bariatric surgery in the Franciscus Gasthuis, Rotterdam, the Netherland |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with morbid obesity enrolled for bariatric surgery at the Franciscus Gasthuis, Rotterdam, the Netherlands.
Key inclusion criteria (5 listed)
- Participants must fulfil all of the inclusion criteria (unless otherwise specified) for enrolment in the study.
- Participants must fulfil the criteria of the International Federation for the Surgery of Obesity (IFSO) at screening.
- Participants must be able to understand the nature of the study and written informed consent must be obtained before any study specific interventions are performed.
- The cardiac function of a subset group of 30 subjects aged 35 years and older with low transient elastography measurements (≤F1) and no known cardiac disease, hypertension or diabetes mellitus will be compared with a similar number of patients with high transient elastography measurements (≥F3) and no known cardiac disease, hypertension or diabetes mellitus. These patients will be consecutively included.
- The investigators will perform a liver biopsy during endoscopic bariatric surgery in the patients with an elevated transient elastography measurement (≥F2; suggesting fibrosis and therefore the presence of NASH) in order to correlate the histological diagnosis to the clinical diagnosis based on elastography. In those patients in whom the diagnosis of NASH is confirmed by histology, more detailed follow up in a separate program at the department of gastroenterology is indicated according to the current guidelines.
Key exclusion criteria (16 listed)
- Patients who meet any of the following criteria at screening (unless otherwise specified) will be excluded from the study:
- Participants younger than 18 years or older than 65 years
- Participants with an established diagnosis of liver pathology like, but not limited to:
- Histologically documented liver cirrhosis (fibrosis stage F4), at screening or in a historical biopsy.
- Participants with active HIV infection and/or treatment.
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 |
|---|---|---|
| NASH screeningEvaluate liver steatosis and elasticity using transient elastography in the FONS group | Diagnostic test | FONS group |
| Cardiac dysfunction screeningEvaluate cardiac dysfunction in 60 patients from the FONS group with transthoracic echocardiography | Diagnostic test | FONS group |
| Liver biopsyFor participants from the FONS group with an elevated liver fibrosis measurement (≥F2) with TE, a laparoscopic liver biopsy will be performed during the bariatric procedure. | Diagnostic test | FONS group |
Primary outcome
Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery
Time frame: baseline (enrolment) and 5 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver steatosis
Change from baseline in liver fibrosis (in kilopascal) 5 years after bariatric surgery
Time frame: baseline (enrolment) and 5 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver fibrosis
18 secondary outcomes
Change from baseline in liver steatosis (in decibel/meter) after lifestyle intervention
Time frame: baseline (enrolment) and 3 months later
Change from baseline in liver fibrosis (in kilopascal) after lifestyle intervention
Time frame: baseline (enrolment) and 3 months later
Change from baseline in liver steatosis (in decibel/meter) 1 year after bariatric surgery
Time frame: baseline (enrolment) and 1 year after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) 1 year after bariatric surgery
Time frame: baseline (enrolment) and 1 year after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) 3 years after bariatric surgery
Time frame: baseline (enrolment) and 3 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) 3 years after bariatric surgery
Time frame: baseline (enrolment) and 3 years after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) according to the type of bariatric surgery
Time frame: baseline and 1 and 3 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) according to the type of bariatric surgery
Time frame: baseline and 1 and 3 years after bariatric surgery
Change from baseline in liver steatosis (in decibel/meter) according to the genetic profile
Time frame: baseline and 1 year after surgery
Change from baseline in liver fibrosis (in kilopascal) according to the genetic profile
Time frame: baseline and 1 year after surgery
Change from baseline in liver steatosis (in decibel/meter) according to gender and ethnicities
Time frame: baseline and 1, 3 and 5 years after bariatric surgery
Change from baseline in liver fibrosis (in kilopascal) according to gender and ethnicities
Time frame: baseline and 1, 3 and 5 years after bariatric surgery
Change from baseline in liver steatosis liver steatosis (in decibel/meter) according to the gut microbiota
Time frame: baseline and 1 year after bariatric surgery
Change from baseline in liver steatosis liver fibrosis (in kilopascal) according to the gut microbiota
Time frame: baseline and 1 year after bariatric surgery
Association between NAFLD/NASH and vascular dysfunction
Time frame: baseline
Association between NAFLD/NASH and cardiac dysfunction
Time frame: baseline and 1 year after bariatric surgery
Association between change in NAFLD/NASH and change in cardiac dysfunction
Time frame: baseline and 1 year after bariatric surgery
Correlation between histology and transient elastography measurement in a population with morbid obesity
Time frame: during 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 27 Aug 2025.
- Derived from this study: PubMed 37400234Theel WB, Boxma-de Klerk BM, Dirksmeier-Harinck F, van Rossum EF, Kanhai DA, Apers JA, van Dalen BM, De Knegt RJ, Neecke B, van der Zwan EM, Grobbee DE, Hankemeier T, Wiebolt J, Castro Cabezas M. Effect of bariatric surgery on NAFLD/NASH: a single-centre observational prospective cohort study. BMJ Open. 2023 Jul 3;13(7):e070431. doi: 10.1136/bmjopen-2022-070431.
- Individual participant dataSharing planned: No. Data are available upon reasonable request. The data that will be shared is individual participant data that underlie the results reported in the study, after deidentification (text, tables, figures and appendices). Also, the study protocol will be available. Data will be available beginning 9 months and ending 36 months following publication, for researchers who provide a methodologically sound proposal for any purpose. Proposals may be directed to w.theel@franciscus. nl up to 36 months following article publication. After 36 months, the data will be available in our hospital's data warehouse but without investigator support other than deposited metadata.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 NAFLD and NASH - Nonalcoholic Steatohepatitis, run by Franciscus Gasthuis at 1 site in Netherlands.
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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. 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 Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery (time frame: baseline (enrolment) and 5 years after bariatric 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 NCT05499949, which also lists 1 linked publication.
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 27 Aug 2025.