Non-Alcoholic Fatty Liver DiseaseNCT03701828
Liver Health and Metabolic Function in People With Obesity
A study testing Weight loss surgery in people with Non-Alcoholic Fatty Liver Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Weight loss surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 19 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index ≥35 kg/m2
- Scheduled for Bariatric surgery
Who cannot join
- Significant organ disfunction/disease
- Tobacco use
- Previous bariatric surgery
- Pregnancy
- Excessive alcohol use
- Liver disease other than NAFLD
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.
Read the detailed 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Weight loss surgery
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss surgeryProcedure or surgery
Also called Sleeve gastrectomy, Roux-en-Y, biliopancreatic diversion
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss | Experimental | Participants will undergo weight loss surgery Receives: Procedure: Weight loss surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver histology
Analysis of liver tissue morphology
Measured: Before and after ~20% weightloss, up to 6 months
Hepatic Fibrogenesis
Rates of liver collagen synthesis
Measured: Before and after ~20% weightloss, up to 6 months
Secondary outcomes (14)
Plasma protein synthesis
Synthesis rates of collagen-related proteins in plasma
Measured: Before and after ~20% weightloss, up to 6 months
Tissue inflammation
adipose tissue and blood immune cell content
Measured: Before and after ~20% weightloss, up to 6 months
Systemic inflammation
Plasma cytokine concentrations
Measured: Before and after ~20% weightloss, up to 6 months
Body composition
Body composition assessed by dual-energy x-ray absorptiometry and magnetic resonance scans
Measured: Before and after ~20% weightloss, up to 6 months
Adipose histology
Assessment of adipose tissue morphology
Measured: Before and after ~20% weightloss, up to 6 months
Tissue gene expression
Messenger ribonucleic acid content of adipose, liver and blood tissues will be assessed
Measured: Before and after ~20% weightloss, up to 6 months
Tissue lipidomics
bioactive lipid content of adipose, liver and blood tissues will be assessed
Measured: Before and after ~20% weightloss, up to 6 months
Insulin sensitivity
Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp
Measured: Before and after ~20% weightloss, up to 6 months
tissue extracellular vesicles
amount, content and function of extracellular vesicles obtained from adipose, liver, and blood tissue
Measured: Before and after ~20% weightloss, up to 6 months
adipose tissue progenitor cells
content and function of progenitor cells obtained from adipose tissue
Measured: Before and after ~20% weightloss, up to 6 months
Liver single cell RNA seq
gene expression of liver immune cell types
Measured: at the time of surgery only
Liver flow cytometry
liver immune cell content
Measured: at the time of surgery only
Liver lipid turnover
Turnover rates of fatty acids and triglycerides
Measured: Before and after ~20% weightloss, up to 6 months
PNPLA3 synthesis
Synthesis rate of liver PNPLA3 protein
Measured: At the time of surgery only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Feb 2019
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701828
- Sponsor's protocol ID
- 201808128
- Status last verified
- Jun 2025
- First submitted
- 10 Sep 2018
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Health and Metabolic Function in People With Obesity
- ClinicalTrials.gov ID
- NCT03701828
- Acronym / sponsor ID
- 201808128
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss | Experimental | Procedure: Weight loss surgeryParticipants will undergo weight loss surgery |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index ≥35 kg/m2
- Scheduled for Bariatric surgery
Key exclusion criteria (6 listed)
- Significant organ disfunction/disease
- Tobacco use
- Previous bariatric surgery
- Pregnancy
- Excessive alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss surgeryAlso: Sleeve gastrectomy, Roux-en-Y, biliopancreatic diversionAll surgery types will be included. However, only participants scheduled for surgery with collaborating surgeons will be included. Surgery is not provided by study team. | Procedure or surgery | Weight loss |
Primary outcome
Liver histology
Time frame: Before and after ~20% weightloss, up to 6 months
Analysis of liver tissue morphology
Hepatic Fibrogenesis
Time frame: Before and after ~20% weightloss, up to 6 months
Rates of liver collagen synthesis
14 secondary outcomes
Plasma protein synthesis
Time frame: Before and after ~20% weightloss, up to 6 months
Tissue inflammation
Time frame: Before and after ~20% weightloss, up to 6 months
Systemic inflammation
Time frame: Before and after ~20% weightloss, up to 6 months
Body composition
Time frame: Before and after ~20% weightloss, up to 6 months
Adipose histology
Time frame: Before and after ~20% weightloss, up to 6 months
Tissue gene expression
Time frame: Before and after ~20% weightloss, up to 6 months
Tissue lipidomics
Time frame: Before and after ~20% weightloss, up to 6 months
Insulin sensitivity
Time frame: Before and after ~20% weightloss, up to 6 months
tissue extracellular vesicles
Time frame: Before and after ~20% weightloss, up to 6 months
adipose tissue progenitor cells
Time frame: Before and after ~20% weightloss, up to 6 months
Liver single cell RNA seq
Time frame: at the time of surgery only
Liver flow cytometry
Time frame: at the time of surgery only
Liver lipid turnover
Time frame: Before and after ~20% weightloss, up to 6 months
PNPLA3 synthesis
Time frame: At the time of surgery only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss surgery in people with Non-Alcoholic Fatty Liver Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver histology (time frame: Before and after ~20% weightloss, up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.