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

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Procedure: bariatric surgery

• Registration Number: NCT05551559
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-12
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	bariatric surgery	-

Primary Outcome Measures

Name	Time	Method
change in severity of NAFLD as determined by magnetic resonance spectroscopy	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 elastography	change between follow-up visit and pre-surgery visit , expected average 10 years	elastography (kPa)
change in concentration of plasma metabolites as determined by nuclear magnetic resonance	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 liver histology	change between follow-up visit and pre-surgery visit , expected average 10 years	liver biopsy from individuals with clinical indication (SAF score)

Trial Locations

Locations (1)

Biomedicum 2U; 🇫🇮 Helsinki, Finland