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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
non-interventional
UZ Brussel
Brussels, Belgium
Serum Markers (sfG) to Follow the Evolution of Liver Damage
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to follow the evolution of liver damage.
Time frame: From time of infomed consent till 1 year after signing informed consent.
Fatty Liver Index (FLI)
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to calculate the Fatty Liver Index to evaluate steatosis. The Fatty Liver Index (FLI) (calculated using TG, GGT, abdominal waist circumference and BMI) was employed to monitor the risk for steatosis. FLI: \< 30 as low risk, 30 to \< 60 as intermediate risk, and ≥ 60 as high risk for liver steatosis.
Time frame: From time of signing the ICF till 1 year after given informed consent
FIB-4 Index
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to calculate the FIB-4 index to evaluate fibrosis. The FIB-4 index is a non-invasive tool used to assess the likelihood of advanced liver fibrosis in individuals, particularly those with conditions like non-alcoholic fatty liver disease (NAFLD) or type 2 diabetes. It combines age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count to generate a score that helps categorize patients into low, intermediate, or high risk for significant liver scarring. FIB-4 index: \< 1,3 for patients \< 64 years or \< 2 for those \> 64 years as low risk (F0-1 = mild fibrosis); 1,3 - 2,67 (\< 64 years) or 2 - 2,67 (\> 64 years) as intermediate risk (F2-3 = moderate fibrosis); and \> 2,67 as high risk for advanced fibrosis (F4 = severe fibrosis to cirrhosis).
Time frame: From time of signing the ICF till 1 year after given informed consent
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to follow the evolution of liver damage.
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Time frame: From time of infomed consent till 1 year after signing informed consent.