The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease (BASIC)
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
bariatric surgery
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Fatty Liver, Liver Diseases, Digestive System Diseases, Bariatric Surgery
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.
Sites / Locations
- Biomedicum 2U
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bariatric surgery
Arm Description
Outcomes
Primary Outcome Measures
change in concentration of plasma metabolites as determined by nuclear magnetic resonance
plasma NMR metabolomics concentrations (mmol/L)
change in severity of NAFLD as determined by elastography
elastography (kPa)
change in severity of NAFLD as determined by magnetic resonance spectroscopy
intrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)
change in severity of NAFLD as determined by liver histology
liver biopsy from individuals with clinical indication (SAF score)
Secondary Outcome Measures
Full Information
NCT ID
NCT05551559
First Posted
September 14, 2022
Last Updated
September 20, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05551559
Brief Title
The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
Acronym
BASIC
Official Title
The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Fatty Liver, Liver Diseases, Digestive System Diseases, Bariatric Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bariatric surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
bariatric surgery
Intervention Description
bariatric surgery
Primary Outcome Measure Information:
Title
change in concentration of plasma metabolites as determined by nuclear magnetic resonance
Description
plasma NMR metabolomics concentrations (mmol/L)
Time Frame
change between follow-up visit and pre-surgery visit , expected average 10 years
Title
change in severity of NAFLD as determined by elastography
Description
elastography (kPa)
Time Frame
change between follow-up visit and pre-surgery visit , expected average 10 years
Title
change in severity of NAFLD as determined by magnetic resonance spectroscopy
Description
intrahepatic triglyceride content by proton magnetic resonance spectroscopy (%)
Time Frame
change between follow-up visit and pre-surgery visit , expected average 10 years
Title
change in severity of NAFLD as determined by liver histology
Description
liver biopsy from individuals with clinical indication (SAF score)
Time Frame
change between follow-up visit and pre-surgery visit , expected average 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panu K Luukkonen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomedicum 2U
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Bariatric Surgery on Hepatic Metabolism in Non-Alcoholic Fatty Liver Disease
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