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The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease

The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05551559
Acronym
BASIC
Enrollment
180
Registered
2022-09-22
Start date
2022-09-12
Completion date
2027-08-31
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Fatty Liver, Liver Diseases, Digestive System Diseases, Bariatric Surgery

Brief summary

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

PROCEDUREbariatric surgery

bariatric surgery

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change in concentration of plasma metabolites as determined by nuclear magnetic resonancechange between follow-up visit and pre-surgery visit , expected average 10 yearsplasma NMR metabolomics concentrations (mmol/L)
change in severity of NAFLD as determined by elastographychange between follow-up visit and pre-surgery visit , expected average 10 yearselastography (kPa)
change in severity of NAFLD as determined by magnetic resonance spectroscopychange between follow-up visit and pre-surgery visit , expected average 10 yearsintrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)
change in severity of NAFLD as determined by liver histologychange between follow-up visit and pre-surgery visit , expected average 10 yearsliver biopsy from individuals with clinical indication (SAF score)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026