Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease) (NAFLD)

April 27, 2022 updated by: Clara Balsano, University of L'Aquila

The aim of the study is to define the relationship between neutrophils, platelets and the activity of T lymphocytes in patients with NAFLD (nonalcoholic fatty liver disease).

This study may predict, in the course of hepatic steatosis, specific phenotypic patterns expressed by PMNs and circulating platelets to evaluate their role in disease progression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy/L'Aquila
      • L'Aquila, Italy/L'Aquila, Italy, 67100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Italian caucasian patients over 18 years old with NAFLD diagnosis

Description

Inclusion Criteria:

  • Patients over 18
  • No alcoholic abuse
  • Hepatic steatosis diagnosticated by abdominal ultrasound
  • Negative hepatitis B and C tests
  • No history of hepatic cirrhosis

Exclusion Criteria:

  • Under 18
  • History of alcoholic abuse
  • Positive serology for hepatitis B or C
  • History of hepatic cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD cohort
Diagnostic test: Data collection
Clinical data collection
Validation cohort
Diagnostic test: Data collection
Clinical data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IL-8(interleukin 8)
Time Frame: 12 months
12 months
Morphology of Circulating Platelets in healthy donors, NAFL, and NASH patients wondering how they may drive and modulate the activity of T cells in this disease
Time Frame: 12 months
12 months
Platelets count in healthy donors, NAFL, and NASH patients
Time Frame: 12 months
12 months
number of Neutrophilis
Time Frame: 12 months
12 months
Morphology of Neutrophilis
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31869

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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