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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05579158
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 19 years who are willing and able to complete all procedures
* Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))
Exclusion Criteria:
* Body mass index (BMI) \<23
* Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease
* Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)
* Significant alcohol intake (\>210g/week for men, \>140g/week for women)
* Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \> 200/120 mmHg)
* Psychiatric illnesses which limit ability to exercise safely
* Diagnosed with diabetes on medication or insulin
* Participation in a weight-loss program within 12 weeks
* MRI contraindications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05579158
Study Brief:
Protocol Section:
NCT05579158