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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT04465032
Eligibility Criteria:
Inclusion Criteria:
* Obese (BMI \> 27 kg/m2)
* Males and postmenopausal females
* Aged 18 to 70 years
* Hepatic steatosis defined as increased hyperechogenicity of the liver on abdominal ultrasound and/or histological signs of steatosis
* Written informed consent
Exclusion Criteria:
* Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc)
* Any other liver disease than NAFLD/NASH
* Present excessive alcohol use defined as \> 2 units/day
* Recent use (\< 3 months) of antibiotics
* use of possible drugs interfering microbiota or recent (\< 3 months) changes in dosages
* use of GLP-1 RA or SU-derivatives
* Recent (\< 3 months) weight change (\>5%)
* Cardiovascular co-morbidity defined as heart failure, coronary insufficiency and hypertension in past history
* Previous use of glucocorticosteroids, hormonal substitution, pagitaxel, theofyllin, amiodarone, myelosuppresive agents.
* A psychiatric, addictive or any other disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04465032
Study Brief:
Protocol Section:
NCT04465032