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

September 20, 2022 updated by: Panu Luukkonen, Helsinki University Central Hospital
The purpose of this study is to investigate the mechanisms underlying bariatric surgery-induced resolution of non-alcoholic fatty liver disease.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00290
        • Biomedicum 2U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bariatric surgery
Procedure: bariatric surgery
bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 between follow-up visit and pre-surgery visit , expected average 10 years
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 between follow-up visit and pre-surgery visit , expected average 10 years
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 between follow-up visit and pre-surgery visit , expected average 10 years
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)
change between follow-up visit and pre-surgery visit , expected average 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Panu K Luukkonen, MD, PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2022

Primary Completion (ANTICIPATED)

August 1, 2026

Study Completion (ANTICIPATED)

August 1, 2027

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (ACTUAL)

September 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS121992022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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