Liver Health and Metabolic Function in People With Obesity

NCT ID: NCT03701828

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2024-02-19

Brief Summary

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

Detailed Description

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Non-alcoholic fatty liver disease (NAFLD) affects approximately 70% of those with obesity and if left untreated can progress to cirrhosis and liver failure. NAFLD stages progress from the stage of simple steatosis to steatohepatitis, and fibrosis The stage of NAFLD is currently best determined using histology from a liver biopsy, however this provides a static depiction of the state of the liver. Therefore, this project aims to determine fibrogenesis in the liver of obese humans in vivo, before and after weight loss.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Weight loss

Participants will undergo weight loss surgery

Group Type EXPERIMENTAL

Weight loss surgery

Intervention Type PROCEDURE

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.

Interventions

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Weight loss surgery

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.

Intervention Type PROCEDURE

Other Intervention Names

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Sleeve gastrectomy, Roux-en-Y, biliopancreatic diversion

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Significant organ disfunction/disease
* Tobacco use
* Previous bariatric surgery
* Pregnancy
* Excessive alcohol use
* Liver disease other than NAFLD
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201808128

Identifier Type: -

Identifier Source: org_study_id

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