Examining the impact of fatty liver disease in bariatric patients
Prognostic Significance of Fatty Liver Disease in Bariatric Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg) |
| Trial ID | NCT03535142 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with active viral hepatitis or contraindications to liver biopsy may not benefit from this study.
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 performed: Other studies have shown varying success in understanding the implications of fatty liver disease in obesity, but this specific approach is relatively novel.
Eligibility criteria
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 this trial is running
Esbjerg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.