Non-Alcoholic Fatty Liver DiseaseBASICNCT05551559
The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
A study testing bariatric surgery in people with Non-Alcoholic Fatty Liver Disease, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- 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
- 180 participants
- Where
- 1 siteFinland
- Study dates
- 12 Sep 2022to Aug 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have undergone bariatric surgery and previously participated in a metabolic study in our research group.
- Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- Age range from 18-75 years.
Who cannot join
- No claustrophobia or metal implants to allow magnetic resonance spectroscopy.
- No pregnancy or lactation in women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.
Read the detailed description
Bariatric surgery is one of the few currently available treatment options for non-alcoholic fatty liver disease (NAFLD). In most cases, NAFLD is entirely ameliorated after the surgery but in some individuals, the disease may persist or even progress. The mechanisms underlying the bariatric surgery-mediated resolution of NAFLD and the heterogeneity in the response remain poorly understood. In this study, the investigators will examine the metabolic effects of bariatric surgery-induced resolution of NAFLD. To this end, study subjects who have previously undergone bariatric surgery and metabolic studies will be invited for a follow-up visit for physical examination, evaluation of body composition with bioelectrical impedance and quantification of liver stiffness using non-invasive transient elastography and magnetic resonance elastography (MRE). Body fat composition will be evaluated by magnetic resonance imaging (MRI) and hepatic lipid content will be measured with magnetic resonance spectroscopy (MRS). In addition, 1H nuclear magnetic resonance (NMR) metabolomic analyses will be carried out from plasma samples collected both before and after bariatric surgery. Insulin resistance will be assessed using the HOMA-IR index and the genotypes in disease-modifying genes including PNPLA3, TM6SF2, MBOAT7, MARC1 and HSD17B13 will be assessed. Liver biopsies were obtained at the time of bariatric surgery and, in individuals with a clinical indication, a follow-up liver biopsy will be obtained.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- bariatric surgery
- Keywords
- Fatty Liver, Liver Diseases, Digestive System Diseases, Bariatric Surgery
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | Not described Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in concentration of plasma metabolites as determined by nuclear magnetic resonance
plasma NMR metabolomics concentrations (mmol/L)
Measured: change between follow-up visit and pre-surgery visit , expected average 10 years
change in severity of NAFLD as determined by elastography
elastography (kPa)
Measured: change between follow-up visit and pre-surgery visit , expected average 10 years
change in severity of NAFLD as determined by magnetic resonance spectroscopy
intrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)
Measured: change between follow-up visit and pre-surgery visit , expected average 10 years
change in severity of NAFLD as determined by liver histology
liver biopsy from individuals with clinical indication (SAF score)
Measured: change between follow-up visit and pre-surgery visit , expected average 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start12 Sep 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panu Luukkonen, Helsinki University Central Hospital
- Investigators
- Panu K Luukkonen, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551559
- Sponsor's protocol ID
- HUS121992022
- Acronym
- BASIC
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05551559
- Acronym / sponsor ID
- BASIC / HUS121992022
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Fatty Liver, Liver Diseases, Digestive System Diseases, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Sep 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 investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.
Detailed description
Bariatric surgery is one of the few currently available treatment options for non-alcoholic fatty liver disease (NAFLD). In most cases, NAFLD is entirely ameliorated after the surgery but in some individuals, the disease may persist or even progress. The mechanisms underlying the bariatric surgery-mediated resolution of NAFLD and the heterogeneity in the response remain poorly understood. In this study, the investigators will examine the metabolic effects of bariatric surgery-induced resolution of NAFLD. To this end, study subjects who have previously undergone bariatric surgery and metabolic studies will be invited for a follow-up visit for physical examination, evaluation of body composition with bioelectrical impedance and quantification of liver stiffness using non-invasive transient elastography and magnetic resonance elastography (MRE). Body fat composition will be evaluated by magnetic resonance imaging (MRI) and hepatic lipid content will be measured with magnetic resonance spectroscopy (MRS). In addition, 1H nuclear magnetic resonance (NMR) metabolomic analyses will be carried out from plasma samples collected both before and after bariatric surgery. Insulin resistance will be assessed using the HOMA-IR index and the genotypes in disease-modifying genes including PNPLA3, TM6SF2, MBOAT7, MARC1 and HSD17B13 will be assessed. Liver biopsies were obtained at the time of bariatric surgery and, in individuals with a clinical indication, a follow-up liver biopsy will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Procedure: bariatric surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have undergone bariatric surgery and previously participated in a metabolic study in our research group.
- Participants must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- Age range from 18-75 years.
Key exclusion criteria (2 listed)
- No claustrophobia or metal implants to allow magnetic resonance spectroscopy.
- No pregnancy or lactation in women.
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 surgerybariatric surgery | Procedure or surgery | Bariatric surgery |
Primary outcome
change in concentration of plasma metabolites as determined by nuclear magnetic resonance
Time frame: change between follow-up visit and pre-surgery visit , expected average 10 years
plasma NMR metabolomics concentrations (mmol/L)
change in severity of NAFLD as determined by elastography
Time frame: change between follow-up visit and pre-surgery visit , expected average 10 years
elastography (kPa)
change in severity of NAFLD as determined by magnetic resonance spectroscopy
Time frame: change between follow-up visit and pre-surgery visit , expected average 10 years
intrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)
change in severity of NAFLD as determined by liver histology
Time frame: change between follow-up visit and pre-surgery visit , expected average 10 years
liver biopsy from individuals with clinical indication (SAF score)
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 22 Sep 2022.
- 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.
Panu K Luukkonen, MD, PhD principal investigator
Helsinki University Central Hospital
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, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 2022. 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 Finland. 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 in concentration of plasma metabolites as determined by nuclear magnetic resonance (time frame: change between follow-up visit and pre-surgery visit , expected average 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2022.