The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bariatric surgery.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure bariatric surgery
bariatric surgery
Primary outcome measures
- 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]
- change in severity of NAFLD as determined by elastography [Time frame: change between follow-up visit and pre-surgery visit , expected average 10 years]
- 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]
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- No claustrophobia or metal implants to allow magnetic resonance spectroscopy.
- No pregnancy or lactation in women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Biomedicum 2U — Helsinki
Identifiers
NCT: NCT05551559 · HUS121992022