NCT03701828

Brief Summary

This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2024

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

September 10, 2018

Last Update Submit

June 17, 2025

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Liver histology

    Analysis of liver tissue morphology

    Before and after ~20% weightloss, up to 6 months

  • Hepatic Fibrogenesis

    Rates of liver collagen synthesis

    Before and after ~20% weightloss, up to 6 months

Secondary Outcomes (14)

  • Plasma protein synthesis

    Before and after ~20% weightloss, up to 6 months

  • Tissue inflammation

    Before and after ~20% weightloss, up to 6 months

  • Systemic inflammation

    Before and after ~20% weightloss, up to 6 months

  • Body composition

    Before and after ~20% weightloss, up to 6 months

  • Adipose histology

    Before and after ~20% weightloss, up to 6 months

  • +9 more secondary outcomes

Other Outcomes (1)

  • PNPLA3 genotype

    Screening only

Study Arms (1)

Weight loss

EXPERIMENTAL

Participants will undergo weight loss surgery

Procedure: Weight loss surgery

Interventions

Weight loss surgeryPROCEDURE

All surgery types will be included. However, only participants scheduled for surgery with collaborating surgeons will be included. Surgery is not provided by study team.

Also known as: Sleeve gastrectomy, Roux-en-Y, biliopancreatic diversion
Weight loss

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index ≥35 kg/m2
  • Scheduled for Bariatric surgery

You may not qualify if:

  • Significant organ disfunction/disease
  • Tobacco use
  • Previous bariatric surgery
  • Pregnancy
  • Excessive alcohol use
  • Liver disease other than NAFLD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Bariatric SurgeryAnastomosis, Roux-en-YBiliopancreatic Diversion

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeAnastomosis, SurgicalDigestive System Surgical ProceduresBiliary Tract Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2018

First Posted

October 10, 2018

Study Start

February 1, 2019

Primary Completion

February 19, 2024

Study Completion

February 19, 2024

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations

US(1)