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

Overview

The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2026

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

Arms, Groups and Cohorts

  • Experimental: Bariatric surgery

Clinical Trial Outcome Measures

Primary 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
    • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Panu Luukkonen, Adjunct Professor – Helsinki University Central Hospital
  • Overall Official(s)
    • Panu K Luukkonen, MD, PhD, Principal Investigator, Helsinki University Central Hospital

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