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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT06275906
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 30 Kg/m2 or an abdominal circumference (waist) \> 94 cm in men and \> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterize metabolic syndrome
* Age range between 18 and 60 years, both sexes
* Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m\], FLI).
Exclusion Criteria:
* Normal weight and underweight subjects
* Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria
* Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis
* Pregnancy or breastfeeding
* Subjects with osteo-articular pathologies that may prevent regular physical exercise
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06275906
Study Brief:
Protocol Section:
NCT06275906