Examining the impact of fatty liver disease in bariatric patients
Official title: Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Run by Esbjerg Hospital - University Hospital of Southern Denmark · NCT03535142 · Data updated 2026-11-12
This study is trying to see how non-alcoholic fatty liver disease affects health outcomes in people with obesity who are having bariatric surgery compared to those who aren't.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg) |
| Status | Recruiting |
| Started | August 15, 2018 |
| Main results expected | June 1, 2035 |
| Study ends | April 1, 2038 |
| Registry record updated | March 5, 2025 |
| Trial ID | NCT03535142 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old with a BMI greater than 35 who are either referred for bariatric surgery or choose not to undergo the procedure.
✕Probably not a fit
Patients with active viral hepatitis or contraindications to liver biopsy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the prevalence and prognostic significance of non-alcoholic fatty liver disease (NAFLD) in patients with a body mass index (BMI) over 35. It involves a prospective non-randomized intervention case control design with 600 bariatric surgery patients and 600 matched control patients who do not undergo surgery. The aim is to understand how fatty liver disease affects outcomes in these individuals. Participants will be monitored for various health outcomes related to their liver condition and obesity.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with fatty liver disease undergoing bariatric surgery.
How similar studies have gone: Other studies have shown varying success in understanding the implications of fatty liver disease in obesity, but this specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria case group: * Age \> 18 years * BMI \>35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark * Able to give written informed consent. Inclusion criteria control group: * Age \> 18 years * BMI \>35 kg/m2 with no wish to undergo bariatric surgery. * Able to give written informed consent. Exclusion Criteria: * Active viral hepatitis * Not willing or able to consent * Contraindications to liver biopsy
Where it's running
-
Hospital of Southwest Jutland
Esbjerg, Denmark Recruiting
Study contacts
- Principal investigator: Mette M Lauridsen, MD, PhD — Esbjerg Hospital - University Hospital of Southern Denmark
- Study coordinator: Mette M Lauridsen, MD PhD
- Email: mette.enok.munk.lauridsen@rsyd.dk
- Phone: 4579182000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Blood markers to detect liver scarring in fatty liver disease
This will test whether blood markers can detect liver scarring in adults with NAFLD or NASH who are having or recently had a liver biopsy.
-
Endoscopic sleeve gastroplasty for people with obesity and MASH
This study will test whether endoscopic sleeve gastroplasty plus lifestyle changes helps adults with obesity and MASH lose weight and improve liver health compared with lifestyle changes alone.
-
Using endoscopic ultrasound to assess liver stiffness in patients with fatty liver disease
This study is testing if a special ultrasound can help find liver damage in people with fatty liver disease who are overweight, comparing it to other methods to see which works best.
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Understanding liver disease linked to alcohol and metabolic syndrome
This study is trying to find out what causes liver cancer in people with alcohol-related liver disease and fatty liver disease by looking at their health, diet, and immune system over several years.
-
Effect of a fibre supplement on children with fatty liver disease
This study is testing whether a fiber supplement can help children aged 8-17 with fatty liver disease improve their liver health over six months.
-
Collecting data to predict cancer risk in at-risk populations
This study is trying to collect samples and health information from people at higher risk of cancer to see if they can find signs that help predict cancer early on.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.