NCT07021443

The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to measure the effect of GLP-1 analogues on non-alcoholic fatty liver disease in patients with diabetes and/or obesity in a clinical context. Previous studies showed a positive effect of this medication, but these studies always took place in highly controlled settings. The question is to what extent liver values evolve in a non-controlled context. The real effect and thus the clinical utility of GLP-1 analogues will be measured.

Detailed description

This study aims to measure the effect of GLP-1 analogues on non-alcoholic fatty liver disease in patients with diabetes and/or obesity in a clinical context. Previous studies showed a positive effect of this medication, but these studies always took place in highly controlled settings. The question is to what extent liver values evolve in a non-controlled context. The real effect and thus the clinical utility of GLP-1 analogues will be measured. Patients in whom a GLP-1 analogue is started (as it would be outside the context of this study) may be recruited. Patients in whom a GLP-1 analogue was started 12 months earlier are also eligible. Once they were screened on the inclusion and exclusion criteria and they took into account and signed the informed consent, they can be definitively included. Participants will be followed for 12 months. There are 2 contact points, the first on the start day and the second after 12 months. During this period, serum markers of liver injury, type 2 diabetes and dyslipidaemia are monitored. With these, additional scores for hepatic steatosis (NAFLD liver fat score) and fibrosis (FIB-4 index) are calculated. A fibroscan (or elastography) is also performed to monitor the evolution of hepatic steatosis and fibrosis. The evolution of data is statistically analysed and hereby compared with the starting points.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
OTHER	non-interventional	non-interventional

Timeline

• Start date: 2023-10-09
• Primary completion: 2023-10-26
• Completion: 2025-05-12
• First posted: 2025-06-15
• Last updated: 2025-08-26
• Results posted: 2025-08-26

Locations

1 site across 1 country: Belgium