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Characterization of the Platelet Inflammatory Response in NAFL and NASH

NCT05128253 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2022-01-13

No results posted yet for this study

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. To characterize and compare the platelet inflammatory phenotype in NAFL vs NASH patients
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

Interventions

OTHER

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

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • Stefania Basili

    lead OTHER

Principal Investigators

  • STEFANIA BASILI, MD · SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2022-09-06
Completion
2023-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128253 on ClinicalTrials.gov