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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05551559

Collaborator

(none)

180

Enrollment

Location

Arm

58.6

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Procedure: bariatric surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 12, 2022

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bariatric surgery	Procedure: bariatric surgery bariatric surgery

Arm

Intervention/Treatment

Experimental: Bariatric surgery

Procedure: bariatric surgery

bariatric surgery

Outcome Measures

Primary Outcome Measures

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 elastography [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 [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 [change between follow-up visit and pre-surgery visit , expected average 10 years]
liver biopsy from individuals with clinical indication (SAF score)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.