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Integrated Phenotyping of the Gut-plAtelet-Liver AXIS in the Progression of Chronic Liver Disease (iGAL-AXIS)

NCT06623084 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2024-10-04

No results posted yet for this study

Summary

Objective of the study Our working hypothesis is that platelets activated by gut-derived metabolites dock in the liver of NAFLD patients and amplify the inflammatory state by releasing pro-inflammatory cytokines/chemokines, which in turn recruit and activate leukocytes in the liver sinusoids. Combined stimuli from leukocytes and platelets would then lead to metabolic reprogramming of hepatocytes, progression to NASH and eventually cirrhosis.

To test this hypothesis, the investigators propose 2 objectives. Primary objective: To identify platelet features that correlate with liver disease progression.

Secondary objective: To study the mechanistic relationship between gut dysbiosis, metabolome composition, inflammation, and platelet activation in chronic liver disease.

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • NASH - Nonalcoholic Steatohepatitis
  • Cirrhosis
  • Control Condition

Interventions

OTHER

Platelets characterization

To identify platelet features that correlate with liver disease progression and to study the mechanistic relationship between gut dysbiosis, metabolome composition, inflammation, and platelet activation in chronic liver disease.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    collaborator OTHER

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Stefania Basili

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-03-12
Completion
2025-12-24

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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 NCT06623084 on ClinicalTrials.gov