Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Research Council, Institute of Clinical Physiology, Italy | OTHER |
| Azienda Ospedaliera Universitaria Mater Domini, Catanzaro | OTHER |
| Federico II University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites. The investigators will assess if PLIN2 and RAB14 can be used not only to identify subjects with NASH and advanced fibrosis but also for monitoring the effect of treatment alone or in combination with other metabolic parameters
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deuterated Water | Experimental | Subjects, enrolled by Operative Federico II University, will be asked to drink the evening before the study 3 mg/kg of deuterated water (2H2O). A blood sample will be taken the morning after an overnight fast and after consuming 2H2O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Deuterated water | Procedure | A blood sample will be taken in the morning after an overnight fast and after consuming deuterated water (2H2O) (3 g/kg body water) the evening before the study day to achieve a plasma water enrichment of 0.3% for the measurement of DNL |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of NASH and Advanced Fibrosis, using PLIN2 and RAB14, in 288 patients undergoing bariatric surgery | PLIN2 and RAB14 will be assessed by flow cytometry in monocytes stored at -80°C from all patients who participated in the BRAVES RCT (288 Subjects). PLIN2 and RAB14 median fluorescent intensity will be used to identify subjects with NASH (NAS >=4) and advanced fibrosis (stage>=2). | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of PLIN2 and RAB14 with non-invasive test for the detection of NASH with significant fibrosis in the CATAMERIS cohort (500 subjects). | 500 Subjects from the CATAMERIS cohort will undergo the following analysis:
PLIN2 and RAB14 accuracy will be compared to Transient elastography, FIB4, APRI and FNI for the dectection of NASH with significant fibrosis |
| Measure | Description | Time Frame |
|---|---|---|
| Understanding the mechanisms underlying the formation, regulation, and metabolism of lipid droplets in the pathogenesis of NAFLD in 40 subjects with NAFLD with or without fibrosis. | 40 subjects with NAFLD with or without fibrosis, assessed with fibroscan, will be asked to drink 3 mg/kg of deuterated water the evening before the study. The following analysis will be performed after the administration of deuterated water : PLIN2 and RAB14 will be assessed by flow cytometry in monocytes Metabolomic and lipidomic analysis will be performed in plasma samples |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geltrude Mingrone | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 18 months |
| 18 months |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |