NAFLD- Non Alcoholic Fatty Liver DiseaseNAFLDNCT05358496
Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)
An observational study of NAFLD- Non Alcoholic Fatty Liver Disease, run by University of L'Aquila at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NAFLD- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Data collection
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Italian caucasian patients over 18 years old with NAFLD diagnosis
Who may be able to join
- Patients over 18
- No alcoholic abuse
- Hepatic steatosis diagnosticated by abdominal ultrasound
- Negative hepatitis B and C tests
- No history of hepatic cirrhosis
Who cannot join
- Under 18
- History of alcoholic abuse
- Positive serology for hepatitis B or C
- History of hepatic cirrhosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Clara Balsano
L’Aquila, Italy/L'Aquila, 67100
Clara Balsano, +390862434774, clara.balsano@univaq.it
About this study
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.
- Conditions
- NAFLD- Non Alcoholic Fatty Liver Disease
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionDiagnostic test
Clinical data collection
| Study group | Role | What they receive |
|---|---|---|
| NAFLD cohort | Not described Receives: Diagnostic Test: Data collection | |
| Validation cohort | Not described Receives: Diagnostic Test: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-8(interleukin 8)
Measured: 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
Measured: 12 months
Platelets count in healthy donors, NAFL, and NASH patients
Measured: 12 months
number of Neutrophilis
Measured: 12 months
Morphology of Neutrophilis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start3 May 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD- Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Balsano, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358496
- Sponsor's protocol ID
- 31869
- Acronym
- NAFLD
- Status last verified
- Apr 2022
- First submitted
- 29 Sep 2021
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)
- ClinicalTrials.gov ID
- NCT05358496
- Acronym / sponsor ID
- NAFLD / 31869
- Conditions
- NAFLD- Non Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD cohort | – | Diagnostic Test: Data collection |
| Validation cohort | – | Diagnostic Test: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Italian caucasian patients over 18 years old with NAFLD diagnosis
Key inclusion criteria (5 listed)
- Patients over 18
- No alcoholic abuse
- Hepatic steatosis diagnosticated by abdominal ultrasound
- Negative hepatitis B and C tests
- No history of hepatic cirrhosis
Key exclusion criteria (4 listed)
- Under 18
- History of alcoholic abuse
- Positive serology for hepatitis B or C
- History of hepatic cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionClinical data collection | Diagnostic test | NAFLD cohort, Validation cohort |
Primary outcome
IL-8(interleukin 8)
Time frame: 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
Platelets count in healthy donors, NAFL, and NASH patients
Time frame: 12 months
number of Neutrophilis
Time frame: 12 months
Morphology of Neutrophilis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD- Non Alcoholic Fatty Liver Disease, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-8(interleukin 8) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.