Non-Alcoholic Fatty Liver DiseasePROMETHEUSNCT03535142
Prognostic Significance of Fatty Liver Disease in Bariatric Patients
A study testing Bariatric surgery in people with Non-Alcoholic Fatty Liver Disease and Metabolic Encephalopathy, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2018to 1 Apr 2038
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- BMI >35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
- Able to give written informed consent.
- Age > 18 years
- BMI >35 kg/m2 with no wish to undergo bariatric surgery.
- Able to give written informed consent.
Who cannot join
- Active viral hepatitis
- Not willing or able to consent
- Contraindications to liver biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Hospital of Southwest Jutland
Esbjerg, 6700
Mette Lauridsen, Postdoc, 61661192, mette.enok.munk.lauridsen@rsyd.dk
About this study
Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis
- Being tested
- Bariatric surgery
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Brain Diseases, Metabolic, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Roux en y gastric bypass or gastric sleeve operation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation). Receives: Procedure: Bariatric surgery |
| Control | No intervention | Age, BMI and co-morbidity matched group who do not undergo surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will die during the follow up period in case and control group
Difference in mortality between cases and controls with various NAFLD severity on biopsy.
Measured: 10 years follow up after inclusion
Secondary outcomes (4)
Number of participant who will experience progressive fatty liver disease in case and control group
Difference NAFLD severity between case and control group after 10 years follow up. Simple steatosis is the mildest form and liver cirrhosis is the most serious manifestation:
- Grade 1 steatosis
- Grade 2 steatosis
- Grade 3 steatosis
- Non alcoholic steatohepatitis
- Presence of fibrosis Kleiner grade 1-2
- Presence of fibrosis Kleiner grade 3
- Presence of liver cirrhosis
Measured: 10 years follow up after inclusion
Change in continuous reaction time measurement after bariatric surgery
Continuous reaction time measurement will measure reaction time instability and is a measure of metabolic encephalopathy. The method is a 10-minutes, computerised registration of a series of motor reaction times to an auditory stimulus, with results reported as the CRTindex (50 percentile/(90-10) percentile) as a parameter of reaction time variability. A CRT index below 1.9 i considerede abnormal a may be a sign of hepatic encephalopathy.
Measured: 10 years follow up after inclusion
Change in EEG after bariatric surgery
Change in mean dominant frequency(MD) on EEG spectral analysis. EEG disturbances in hepatic encephalopathy are (rated by severity)but there is no enough space here to describe it.
Measured: 24 months after surgery
Change in intelligence quotient after bariatric surgery
Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150.
Measured: 24 months efter surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start15 Aug 2018
- Primary completion1 Jun 2035 (estimated)
- Study completion1 Apr 2038 (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 Non-Alcoholic Fatty Liver DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital, Esbjerg University Hospital of South-West Jutland
- Responsible party
- Principal investigator, Mette Munk Lauridsen, University of Southern Denmark
- Investigators
- Mette M Lauridsen, MD, PhD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535142
- Sponsor's protocol ID
- S-20170210
- Acronym
- PROMETHEUS
- Status last verified
- Mar 2025
- First submitted
- 1 May 2018
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug.
PubMed 40677693
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Fatty Liver Disease in Bariatric Patients
- ClinicalTrials.gov ID
- NCT03535142
- Acronym / sponsor ID
- PROMETHEUS / S-20170210
- Conditions
- Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital, Esbjerg University Hospital of South-West Jutland
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 1 Jun 2035 (estimated)
- Study completion
- 1 Apr 2038 (estimated)
- First posted
- 24 May 2018 (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.
Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Bariatric surgeryThe intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation). |
| Control | No intervention | –Age, BMI and co-morbidity matched group who do not undergo surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- BMI >35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
- Able to give written informed consent.
- Age > 18 years
- BMI >35 kg/m2 with no wish to undergo bariatric surgery.
Key exclusion criteria (3 listed)
- Active viral hepatitis
- Not willing or able to consent
- Contraindications to liver biopsy
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 |
|---|---|---|
| Bariatric surgeryRoux en y gastric bypass or gastric sleeve operation | Procedure or surgery | Intervention |
Primary outcome
Number of participants who will die during the follow up period in case and control group
Time frame: 10 years follow up after inclusion
Difference in mortality between cases and controls with various NAFLD severity on biopsy.
4 secondary outcomes
Number of participant who will experience progressive fatty liver disease in case and control group
Time frame: 10 years follow up after inclusion
Change in continuous reaction time measurement after bariatric surgery
Time frame: 10 years follow up after inclusion
Change in EEG after bariatric surgery
Time frame: 24 months after surgery
Change in intelligence quotient after bariatric surgery
Time frame: 24 months efter 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 5 Mar 2025.
- Derived from this study: PubMed 40677693Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug.
- Individual participant dataSharing planned: No
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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.
Mette M Lauridsen, MD, PhD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Non-Alcoholic Fatty Liver Disease and Metabolic Encephalopathy, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 6 inclusion and 3 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 5 Mar 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 Denmark. 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 Mette M Lauridsen, MD PhD (4579182000, mette.enok.munk.lauridsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who will die during the follow up period in case and control group (time frame: 10 years follow up after inclusion). 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 NCT03535142, 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 5 Mar 2025.