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Completed

NCT Number: NCT03701828

Liver Health and Metabolic Function in People With Obesity

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

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight loss surgery

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.

Other names: Sleeve gastrectomy, Roux-en-Y, biliopancreatic diversion

Primary outcomes

  1. Liver histology

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

    Analysis of liver tissue morphology

  2. Hepatic Fibrogenesis

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

    Rates of liver collagen synthesis

Secondary outcomes

  1. Plasma protein synthesis

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

    Synthesis rates of collagen-related proteins in plasma

  2. Tissue inflammation

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

    adipose tissue and blood immune cell content

  3. Systemic inflammation

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

    Plasma cytokine concentrations

  4. Body composition

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

    Body composition assessed by dual-energy x-ray absorptiometry and magnetic resonance scans

  5. Adipose histology

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

    Assessment of adipose tissue morphology

  6. Tissue gene expression

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

    Messenger ribonucleic acid content of adipose, liver and blood tissues will be assessed

  7. Tissue lipidomics

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

    bioactive lipid content of adipose, liver and blood tissues will be assessed

  8. Insulin sensitivity

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

    Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp

  9. tissue extracellular vesicles

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

    amount, content and function of extracellular vesicles obtained from adipose, liver, and blood tissue

  10. adipose tissue progenitor cells

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

    content and function of progenitor cells obtained from adipose tissue

  11. Liver single cell RNA seq

    Time frame: at the time of surgery only

    gene expression of liver immune cell types

  12. Liver flow cytometry

    Time frame: at the time of surgery only

    liver immune cell content

  13. Liver lipid turnover

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

    Turnover rates of fatty acids and triglycerides

  14. PNPLA3 synthesis

    Time frame: At the time of surgery only

    Synthesis rate of liver PNPLA3 protein

Other outcomes

  1. PNPLA3 genotype

    Time frame: Screening only

    genotyping for the PNPLA3 SNP rs738409 will be determined

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2018
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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