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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— BASIC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05551559
• Other study ID #: HUS121992022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: August 2027

Study information

• Verified date: September 2022
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: August 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Procedure:
• bariatric surgery
bariatric surgery

Locations

Country	Name	City	State
Finland	Biomedicum 2U	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in concentration of plasma metabolites as determined by nuclear magnetic resonance	plasma NMR metabolomics concentrations (mmol/L)	change between follow-up visit and pre-surgery visit , expected average 10 years
Primary	change in severity of NAFLD as determined by elastography	elastography (kPa)	change between follow-up visit and pre-surgery visit , expected average 10 years
Primary	change in severity of NAFLD as determined by magnetic resonance spectroscopy	intrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)	change between follow-up visit and pre-surgery visit , expected average 10 years
Primary	change in severity of NAFLD as determined by liver histology	liver biopsy from individuals with clinical indication (SAF score)	change between follow-up visit and pre-surgery visit , expected average 10 years