NCT05551559

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Sep 2022Aug 2027

Study Start

First participant enrolled

September 12, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

3.9 years

First QC Date

September 14, 2022

Last Update Submit

September 20, 2022

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Fatty LiverLiver DiseasesDigestive System DiseasesBariatric Surgery

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Bariatric surgery

EXPERIMENTAL
Procedure: bariatric surgery

Interventions

bariatric surgeryPROCEDURE

bariatric surgery

Bariatric surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No claustrophobia or metal implants to allow magnetic resonance spectroscopy.
  • No pregnancy or lactation in women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedicum 2U

Helsinki, 00290, Finland

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty LiverLiver DiseasesDigestive System Diseases

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Panu K Luukkonen, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 22, 2022

Study Start

September 12, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)