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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT06647095
Eligibility Criteria:
Inclusion Criteria for Participants with MASLD:
* Presence of liver steatosis (detected either by hepatic ultrasonography/CAP/histologically) or MASH/simple steatosis confirmed by liver biopsy
* Absence of secondary causes of fat accumulation in the liver and other liver disease: ruled out other etiologies of liver disease, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, biliary tract disease, and hereditary metabolic diseases
Inclusion Criteria for Negative Controls:
* Absence of liver disease
* For breath analysis: absence of liver steatosis (normal liver ultrasound image and CAP less than 248 dB/m)
* For plasma spectroscopy and bile acid analysis: Body Mass Index ≤ 25 and waist-hip ratio ≤ 0.95 plus normal liver ultrasound
* Absence of diabetes mellitus and metabolic syndrome
* Normal liver function tests, lipid spectrum, fasting glycemia
* Alcohol intake less than 20 g/ day (women) or 30 g/ day (men)
Exclusion Criteria:
* Non-compliance with the investigation program
* Failure to sign the informed consent form
* Liver biopsy/clinic discrepancy
* For LMN a TMA "stress test": fish, see fruit and citrus fruit allergy
* Pregnancy
* For bile acid analysis: Treatment with BA or BA sequestrants
* For bile acid analysis: Portal hypertension (does not apply for MASH patients)
* For bile acid analysis: Cirrhosis (does not apply for MASH patients)
* For plasma spectroscopy: Cirrhosis
* Anamnesis of alcohol abuse (based on GGT, carbohydrate-deficient transferrin, urinary ethyl-glucuronide, and patient's history)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06647095
Study Brief:
Protocol Section:
NCT06647095