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Enrolling by Invitation

NCT Number: NCT05551559

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

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

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedicum 2U

Helsinki, 00290, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

bariatric surgery

Primary outcomes

  1. 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)

  2. 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)

  3. 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 (%)

  4. 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)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: BASIC

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2022
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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