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NCT07021443Completed

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
50 (actual)
First submitted
9 May 2023
Start date
9 Oct 2023
Primary completion date
26 Oct 2023
Lead sponsor
Universitair Ziekenhuis Brussel
NCT number
NCT07021443

What you commit to

  • Study type: Observational
  • Participants enrolled: 50
  • From 9 Oct 2023 to the primary completion date, 26 Oct 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient suffers from drug induced liver steatosis. Drugs warranting exclusion include glucocorticoids, amiodarone, tamoxifen, methotrexate, valproate, tetracycline and chemotherapeutic agents.

Other illness

  • The patient suffers from any other chronic liver disease. These will be checked trough lab test results in the patients file.

Lab values

  • 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.

Other

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UZ Brussel
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.