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

NCT07021443 | Completed Results

• 1 other identifier: GLP1_NAFLD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  From time of infomed consent till 1 year after signing informed consent.

Interventions

non-interventional OTHER

non-interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from consultations in the diabetes- and obesity clinic in UZ Brussel. All diabetic and/or obese patients with objectified NAFLD starting a GLP-1 analogue, or whom have started a GLP-1 analogue 12 months prior, will be considered as possible candidates. Inclu-sion is definite after it is established that patients comply to all inclusion- and exclusion criteria and they agree to the informed consent.

You may qualify if:

• The patient is older than 18 years old.
• The patient has obesity, defined as a BMI of 30 or higher; and/or the patient suffers from T2DM, defined as a twice measured sfG of 125 mg/dl or higher, or a sfG of 100 to 125 mg/dl and a twice measured oral glucose tolerance test (OGTT) with a serum glucose (sG) of 200 mg/dl, or higher after 2 hours, or a random sG of 200 mg/dl or higher in symptomatic patients.
• The patient suffers from NAFLD in any stage, except cirrhosis. This has to be objec-tively diagnosed by either a CAP fibroscan (cutoff: \> 238 dB/m); or by the calculated NAFLD liver fat score (cutoff: \> -0,64), at least one of which has to be positive.
• The patient is starting a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study; or the patient has started a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study 12 months prior.
• If the patient is part of the retro-prospective branch data collected 12 months prior include at least a (CAP) fibroscan, a blood sample (measuring AST, ALT, GGT, sfG, sfI, HbA1c, HDL, LDL, total cholesterol and platelets) and a physical examination (measuring blood pressure, waist circumference, weight and length).

You may not qualify if:

• The patient suffers from alcohol induced fatty liver disease. Macrocytic anemia; de-creased vitamin B12 and folic acid; increased GGT, bilirubin, ferritin, TG and AST/ALT ratio can be used as serum markers of alcohol abuse. Interpretation of these results will be the left to the patient's clinician and their clinical expertise. Alterna-tively a weekly alcohol consumption of 21 units for men and 14 units for women can be used as a cutoff.
• The patient suffers from any other chronic liver disease. These will be checked trough lab test results in the patients file.
• The patient has liver cirrhosis, defined as a fibroscan score of 14 kPa or more; or a FIB-4 index of \> 2,67. Elastography
• The patient is pregnant at time of enrolment or at any time during the study.
• The patient refuses to agree to the informed consent.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Prof. dr. Hendrik Reynaert
• Organization: UZ Brussel

hendrik.reynaert@uzbrussel.be

+32 2 477 68 11

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 15, 2025
• Study Start: October 9, 2023
• Primary Completion: October 26, 2023
• Study Completion: May 12, 2025
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)