fatty liver, liver fibrosis Fatty liver, scar tissue in the liver
Conditions
Interventions
None listed
Sponsors
Julius Clinical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18-75 year old; - new or established diagnosis of at least 1 of the following 4 conditions: type 2 diabetes mellitus, obesity, arterial hypertension or metabolic syndrome (diagnostic criteria defined in protocol).
Exclusion criteria
Exclusion criteria: - The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, Wilson*s disease, sarcoidosis, etc); - The patient is known with any other condition that may lead to liver fibrosis or cirrhosis; - The patient engages in (Excessive) alcohol use (defined as > 3 units/day in males [30 grams/day] and > 2 units/day in females [20 grams/day]); - The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient*s safety or ability to be included in this study; -The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel; - The patient is not able to understand the details of the protocol and/or is not able to provide written informed consent; - The patient is pregnant or breastfeeding. - The patient underwent bariatric surgery in the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Steatosis stage deduced from controlled attenuation parameter (CAP)measurement with FibroScan; MASLD definition (CAP > 280 and 1 out of 5 cardiometabolic risk factors); b. Fibrosis stage deduced from liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) measurement with FibroScan c. At-risk MASH deduced from FAST score d. MASH diagnosis confirmed by histology (NAS/SAF criteria) upon liver biopsy; c. Prevalences (see a. to d.) stratified per country; d. Number of patients at-risk identified by FIB-4 in comparison to numbers found using LSM by VCTE with FibroScan measurements, and numbers found in combination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline clinical characteristics; genomic and proteomic analysis; metabolomic and lipidomic analyses; fluxomics analysis; prevalence comorbidities; prognostic factors; 2. PRO surveys at baseline and follow-up; 3. Revisited FibroScan measurements (CAP and LSM by VCTE) 12 weeks after of lifestyle recommendations; 4. Repeated CAP, LSM by VCTE and FAST measurement over time. | — |
Countries
Belgium, Czech Republic, France, Germany, Greece, Italy, Netherlands, Portugal, Romania, Spain
Contacts
Public ContactV Jong
Julius Clinical
Outcome results
None listed