The Effect of Bariatric Surgery on Hepatic Metabolism in... | NCT05551559

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

NCT05551559

Sponsor

Helsinki University Central Hospital

Status

Enrolling by invitation

Last Update Posted

Sep 22, 2022Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

bariatric surgery

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2022Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Sep 14, 2022

First Submission Date that Met QC Criteria

Sep 20, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2022

Last Update Posted Date

Sep 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Panu Luukkonen, Adjunct Professor, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric surgery	Experimental		Procedure: bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bariatric surgery	Procedure	bariatric surgery	Bariatric surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
change in severity of NAFLD as determined by elastography	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	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	liver biopsy from individuals with clinical indication (SAF score)	change between follow-up visit and pre-surgery visit , expected average 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Panu K Luukkonen, MD, PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biomedicum 2U		Helsinki		00290	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided