Liver Health and Metabolic Function in People With Obesity

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Liver Health and Metabolic Function in People With Obesity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03701828
• Other study ID #: 201808128
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic Fibrogenesis	Rates of liver collagen synthesis	Before and after ~20% weightloss, up to 6 months
Primary	Liver histology	Analysis of liver tissue morphology	Before and after ~20% weightloss, up to 6 months
Secondary	Plasma protein synthesis	Synthesis rates of collagen-related proteins in plasma	Before and after ~20% weightloss, up to 6 months
Secondary	Tissue inflammation	adipose tissue and blood immune cell content	Before and after ~20% weightloss, up to 6 months
Secondary	Systemic inflammation	Plasma cytokine concentrations	Before and after ~20% weightloss, up to 6 months
Secondary	Tissue bacterial contamination	bacterial 16s ribosomal ribonucleic acid content will be assessed in blood and tissue samples	Before and after ~20% weightloss, up to 6 months
Secondary	Body composition	Body composition assessed by dual-energy x-ray absorptiometry and magnetic resonance scans	Before and after ~20% weightloss, up to 6 months
Secondary	Intestinal permeability	Urinary excretion of indigestible sugars will be assessed over 24 hours after an oral challenge	Before and after ~20% weightloss, up to 6 months
Secondary	Adipose histology	Assessment of adipose tissue morphology	Before and after ~20% weightloss, up to 6 months
Secondary	Tissue gene expression	Messenger ribonucleic acid content of adipose, liver and blood tissues will be assessed	Before and after ~20% weightloss, up to 6 months
Secondary	Tissue lipidomics	bioactive lipid content of adipose, liver and blood tissues will be assessed	Before and after ~20% weightloss, up to 6 months
Secondary	Insulin sensitivity	Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp	Before and after ~20% weightloss, up to 6 months
Secondary	tissue extracellular vesicles	amount, content and function of extracellular vesicles obtained from adipose, liver, and blood tissue	Before and after ~20% weightloss, up to 6 months
Secondary	Liver extracellular vesicles	amount, content and function of extracellular vesicles obtained from liver tissue	at the time of surgery only
Secondary	adipose tissue progenitor cells	content and function of progenitor cells obtained from adipose tissue	Before and after ~20% weightloss, up to 6 months
Secondary	Liver single cell RNA seq	gene expression of liver immune cell types	at the time of surgery only
Secondary	Liver flow cytometry	liver immune cell content	at the time of surgery only