Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT05220956
Eligibility Criteria:
Patients with steady medication during the last 3 months. A diabetes mellitus must not be decompensated (HbA1c \<6.5%). Patients with advanced fibrosis - defined about the non-invasive Fibroscan-procedure (Fibroscan \>13 kPa) - will not be included.
Complete inclusion criteria:
1. Age between 18 and 75 years
2. Body Mass Index (BMI) \> 25 kg/m2
3. Grade 3 steatosis evaluated by with CAP ≥ 300 dB/m and exclusion of known causes of liver steatosis
4. Liver elastography \< 13 kPa
5. Capability to understand the study and the individual consequences of participation
6. Signed and dated declaration of agreement in the forefront of the study
Complete exclusion criteria:
1. Liver cirrhosis
2. Hepatocellular carcinoma or non-curative treated carcinoma
3. Alcohol consumption \>20g (female) und \>30 g (male)/day
4. Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson disease, α-1-Antitrypsin deficiency
5. Medications which cause liver disease or secondary NAFLD (e. g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
6. Changes in body weight \> 5% in the last 6 months
7. Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks
8. Uncontrolled diabetes type 2 defined as HbA1c value \> 9.0% or insulin depending type 2 diabetes
9. Pregnancy
10. Immunologic or inflammatory disease (e. h. systemic lupus erythematodes)
11. Patients after organ transplantations
12. Missing or lacking consent capability
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05220956
Study Brief:
Protocol Section:
NCT05220956