Prognostic Significance of Fatty Liver Disease in Bariatric Patients
Recruiting · NCT03535142 · Interventional (participants receive a specific treatment) · Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
View the official record on ClinicalTrials.gov →Interventions studied
Bariatric surgery
What this trial is about
Prospective non-randomized intervention case control study on patients with a BMI \> 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Hospital of Southwest Jutland - Esbjerg, Denmark