Clinical trial NCT05551559: The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
Official title: The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Fatty Liver
Liver Diseases
Digestive System Diseases
Bariatric Surgery
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in concentration of plasma metabolites as determined by nuclear magnetic resonance
timeFrame: change between follow-up visit and pre-surgery visit , expected average 10 years
measure: change in severity of NAFLD as determined by elastography
timeFrame: change between follow-up visit and pre-surgery visit , expected average 10 years
measure: change in severity of NAFLD as determined by magnetic resonance spectroscopy
timeFrame: change between follow-up visit and pre-surgery visit , expected average 10 years
measure: change in severity of NAFLD as determined by liver histology
timeFrame: change between follow-up visit and pre-surgery visit , expected average 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Biomedicum 2U
Study officials:
affiliation: Helsinki University Central Hospital
name: Panu K Luukkonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: