Characterization of the Platelet Inflammatory Response in NAFL and NASH

NCT05128253 | Unknown

• 1 other identifier: 6216
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to identify which features of platelet activation promote the inflammatory response that underlies the progression from NAFL to NASH. Therefore, the investigators plan:

1. 1.To characterize and compare the platelet inflammatory phenotype in NAFL vs NASH patients
2. 2.To study if and how the signaling pathways controlled by ITAM/ITIM-coupled receptors is dysregulated in NAFL vs NASH As a secondary objective the investigators will analyze platelet activation and inflammatory response in a subset of NAFL and NASH patients after 2, 4 and 6 hours from consumption of a high fat meal to test if and how the platelet inflammatory phenotype is promoted by post-prandial plasma lipids.

Conditions

NASH - Nonalcoholic Steatohepatitis; NAFLD

Keywords

platelets; inflammation

Outcome Measures

Primary Outcomes (1)

• Concentration of platelet-leukocyte aggregates (evaluated as median fluorescence intensity -MFI- of platelets bound to leukocytes) in whole blood in patients with NAFLD and NASH

  Platelet leukocyte aggregates are a sensitive surrogate marker of platelet activation. The level of platelet-leukocyte aggregates will be measured directly in anticoagulated whole blood, within 30 minutes from withdrawal. By multicolor flow cytometry the investigators will detect the percentage of leukocyte that stain positive for CD41a, a specific marker platelets. The investigators expect to detect a relevant difference in platelet-leukocytes aggregates of 10% between NASH and NAFLD patients.

  1 year

Study Arms (2)

NASH GROUP

Recruited (n=22) patients with non-alcoholic steatohepatitis.

Other: High fat meal in a subset of patients with NAFL or NASH

NAFL GROUP

Recruited (n=22) patients with non-alcoholic fatty liver.

Other: High fat meal in a subset of patients with NAFL or NASH

Interventions

High fat meal in a subset of patients with NAFL or NASH OTHER

In a subset of NAFL (n=11) and NASH (n=11) patients venous blood samples will also be taken 2 (T0+2h), 4 (T0+4h) and 6 (T0+6h) hours after consumption of a high fat meal.

NAFL GROUP; NASH GROUP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 44 patients (22 with NAFL and 22 NASH) will be enrolled at the Policlinico Umberto I-Sapienza University of Rome, defined according to the EASL Guidelines 2016.

You may qualify if:

• Aged 18 years or older
• Written informed consent
• Both sexes
• Patients with NAFL and NASH according to EASL Guidelines 2016.

You may not qualify if:

• Patients on anti-platelet or anti-coagulant medications
• Reported severe immunosuppression
• Uncontrolled diabetes mellitus type 2 (HbA1c \>7.0 %)
• Patients receiving PPAR-gamma and PPAR-alpha agonists
• Uncompensated cirrhosis defined as the presence of at least one of the following features: current or past cirrhosis complications (e.g. ascites, variceal gastrointestinal bleeding, hepatic encephalopathy), the presence of hyperbilirubinaemia (\>2 mg/dl), hypoalbuminaemia (\<3.2 g/dl), prolonged INR (\>1.7), low platelet count, gastroesophageal varices at endoscopy.
• preexisting medical condition with a life expectancy of less than 3 months

Sponsors & Collaborators

• Stefania Basili: lead
• University of Roma La Sapienza: collaborator

Study Sites (2)

Policlinico Umberto Primo - Sapienza University of Rome

Rome, 00161, Italy

NOT YET RECRUITING

Sapienza University of Rome - Policlinico Umberto I Roma

Rome, 00161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous Blood will be centrifuged within 2 hours and plasma and serum samples will be stored at -80°C for further analysis.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Inflammation

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• STEFANIA BASILI, MD

  SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Stefanini, PhD

CONTACT

+390649972018; lucia.stefanini@uniroma1.it

Stefano Ginanni Corradini, MD

CONTACT

+390649972018; stefano.corradini@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Stefania Basili

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: November 19, 2021
• Study Start: December 6, 2021
• Primary Completion: September 6, 2022
• Study Completion: August 31, 2023
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)