NASH - Nonalcoholic SteatohepatitisNCT05128253
Characterization of the Platelet Inflammatory Response in NAFL and NASH
An observational study of NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Stefania Basili at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, NAFLD
- What is being tested?
- High fat meal in a subset of patients with NAFL or NASH
- How many people
- 44 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Dec 2021to 31 Aug 2023
- 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 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Aged 18 years or older
- Written informed consent
- Both sexes
- Patients with NAFL and NASH according to EASL Guidelines 2016.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Not yet recruiting
Policlinico Umberto Primo - Sapienza University of Rome
Rome, 00161
STEFANIA BASILI, MD, 3393452523, stefania.basili@uniroma1.it
Roberto Cangemi, MD, +393358093936, roberto.cangemi@uniroma1.it
- Recruiting
Sapienza University of Rome - Policlinico Umberto I Roma
Rome, 00161
Stefania Basili, MD, +390649972018, stefania.basili@uniroma1.it
Roberto Cangemi, MD, +390649972018, roberto.cangemi@uniroma1.it
About this study
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:
- To characterize and compare the platelet inflammatory phenotype in NAFL vs NASH patients
- 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.
Read the detailed description
Background NonAlcoholic Fatty Liver Disease (NAFLD) is one of the most commonly encountered liver disorders worldwide. NAFLD is a spectrum of liver disease including (i) simple hepatic steatosis also called Non-Alcoholic Fatty Liver (NAFL) and (ii) Non-alcoholic SteatoHepatitis (NASH).
When more than 5% hepatic steatosis is present, patients are considered to have NAFL. If steatosis is present along with hepatocyte ballooning degeneration and lobular inflammation, patients are considered to have NASH. About 20% of patients with NAFLD have NASH.
Over time, NAFLD may progress to cirrhosis and ultimately to hepatocellular carcinoma (HCC) with a greater proportion of NASH patients (20%).
Platelets are specialized blood cells that continuously monitor and preserve the integrity of the cardiovascular system. Beyond their well-established role in hemostasis, platelets have been recently shown to actively participate in the inflammatory response and in tissue remodeling, by releasing bioactive molecules and by interacting with leukocytes.
The liver-platelet relationship is very complex. In physiological conditions the liver regulates platelet number by producing thrombopoietin and platelet lifespan by clearing aged platelets. In pathological conditions, increasing evidence demonstrate that platelets have an important role in regulating liver inflammation and chronic disease. Platelet-derived cytokines, such as TGF-β, platelet-derived growth factor-β (PDGF-β), and CXCL4, promote hepatic fibrosis, and platelet count has been used for many years as a surrogate marker of liver fibrosis (FIB-4 index). Recent studies demonstrate that platelet number and platelet aggregation are increased in liver sinusoids of NASH patients. Mechanistic insights provided by mouse models suggest that the role of platelets in NAFLD progression is mediated through the interaction with immune cells. Platelet colonization of the liver is mediated through the interaction with specialized macrophages lining the liver sinusoids (Kupffer cells) and it is a critical step for the recruitment of CD8+ T cells and NKT cells, which drive NASH progression through the release of cytokines and the metabolic reprogramming of hepatocytes. The importance of platelets in the development of NASH and subsequent progression to cirrhosis and HCC has been confirmed in humans by inhibiting platelets with a combination of aspirin and clopidogrel in a small pilot case study.
There is mounting evidence suggesting that distinct signaling pathways regulate the hemostatic and the inflammatory function of platelets. For instance, the platelet ITAM- (GPVI, CLEC2) and ITIM- (PECAM-1, TLT-1) coupled receptors regulate the platelet inflammatory response but have a minor role in hemostasis. Thus, one could envisage targeting the platelet inflammatory response as a strategy to limit the progression of NAFLD, without undermining hemostasis.
Hypotheses The overarching hypothesis of the proposed project is that platelets amplify the inflammatory state that drives the progression from NAFL to NASH.
Platelets participate in the inflammatory response by releasing bioactive compounds and establishing heterotypic interactions with leukocytes. However, these mechanisms in the context of chronic liver disease are poorly understood and have been studied mainly in mice.
Our working model is that platelets docked in the liver of NAFLD patients amplify the inflammatory state by releasing pro-inflammatory cytokines, 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 and progression to NASH. In this context the investigators expect to identify an important role of GPVI and CLEC-2 and their inhibitory counterparts PECAM-1 and TLT-1, which are critically implicated in the regulation of platelet activation at sites of inflammation.
The investigators anticipate that features of the platelet inflammatory response could be both sensitive and sex-specific biomarkers for NASH progression and novel therapeutic targets.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD
- Being tested
- High fat meal in a subset of patients with NAFL or NASH
- Keywords
- platelets, inflammation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat meal in a subset of patients with NAFL or NASHOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NASH GROUP | Recruited (n=22) patients with non-alcoholic steatohepatitis. Receives: Other: High fat meal in a subset of patients with NAFL or NASH | |
| NAFL GROUP | Recruited (n=22) patients with non-alcoholic fatty liver. Receives: Other: High fat meal in a subset of patients with NAFL or NASH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start6 Dec 2021
- Primary completion6 Sep 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefania Basili
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Sponsor-investigator, Stefania Basili, University of Roma La Sapienza
- Investigators
- STEFANIA BASILI, MD, Principal investigator, SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128253
- Sponsor's protocol ID
- 6216
- Status last verified
- Dec 2021
- First submitted
- 6 Jul 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maiorca F, Sabetta A, Sangineto M, Pallucci D, Dufies O, Poli V, Di Gioia M, D'Amico T, Miglionico M, Lombardi L, Ciarnelli M, Signorile G, D'Amati G, Romiti GF, Cangemi R, Visentini M, Raparelli V, Serviddio G, Basili S, Zanoni I, Stefanini L; Precision Medicine Liver Group. Hypermetabolic State Drives Platelet Dysfunction in Human and Mouse Metabolic Dysfunction-Associated Steatotic Liver Disease. Arterioscler Thromb Vasc Biol. 2026 Oct 1. doi: 10.1161/ATVBAHA.126.325001. Online ahead of print.
PubMed 42817874
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Platelet Inflammatory Response in NAFL and NASH
- ClinicalTrials.gov ID
- NCT05128253
- Acronym / sponsor ID
- 6216
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD
- Keywords
- platelets, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Stefania BasiliUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Sep 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 19 Nov 2021 (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 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:
- To characterize and compare the platelet inflammatory phenotype in NAFL vs NASH patients
- 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.
Detailed description
Background NonAlcoholic Fatty Liver Disease (NAFLD) is one of the most commonly encountered liver disorders worldwide. NAFLD is a spectrum of liver disease including (i) simple hepatic steatosis also called Non-Alcoholic Fatty Liver (NAFL) and (ii) Non-alcoholic SteatoHepatitis (NASH).
When more than 5% hepatic steatosis is present, patients are considered to have NAFL. If steatosis is present along with hepatocyte ballooning degeneration and lobular inflammation, patients are considered to have NASH. About 20% of patients with NAFLD have NASH.
Over time, NAFLD may progress to cirrhosis and ultimately to hepatocellular carcinoma (HCC) with a greater proportion of NASH patients (20%).
Platelets are specialized blood cells that continuously monitor and preserve the integrity of the cardiovascular system. Beyond their well-established role in hemostasis, platelets have been recently shown to actively participate in the inflammatory response and in tissue remodeling, by releasing bioactive molecules and by interacting with leukocytes.
The liver-platelet relationship is very complex. In physiological conditions the liver regulates platelet number by producing thrombopoietin and platelet lifespan by clearing aged platelets. In pathological conditions, increasing evidence demonstrate that platelets have an important role in regulating liver inflammation and chronic disease. Platelet-derived cytokines, such as TGF-β, platelet-derived growth factor-β (PDGF-β), and CXCL4, promote hepatic fibrosis, and platelet count has been used for many years as a surrogate marker of liver fibrosis (FIB-4 index). Recent studies demonstrate that platelet number and platelet aggregation are increased in liver sinusoids of NASH patients. Mechanistic insights provided by mouse models suggest that the role of platelets in NAFLD progression is mediated through the interaction with immune cells. Platelet colonization of the liver is mediated through the interaction with specialized macrophages lining the liver sinusoids (Kupffer cells) and it is a critical step for the recruitment of CD8+ T cells and NKT cells, which drive NASH progression through the release of cytokines and the metabolic reprogramming of hepatocytes. The importance of platelets in the development of NASH and subsequent progression to cirrhosis and HCC has been confirmed in humans by inhibiting platelets with a combination of aspirin and clopidogrel in a small pilot case study.
There is mounting evidence suggesting that distinct signaling pathways regulate the hemostatic and the inflammatory function of platelets. For instance, the platelet ITAM- (GPVI, CLEC2) and ITIM- (PECAM-1, TLT-1) coupled receptors regulate the platelet inflammatory response but have a minor role in hemostasis. Thus, one could envisage targeting the platelet inflammatory response as a strategy to limit the progression of NAFLD, without undermining hemostasis.
Hypotheses The overarching hypothesis of the proposed project is that platelets amplify the inflammatory state that drives the progression from NAFL to NASH.
Platelets participate in the inflammatory response by releasing bioactive compounds and establishing heterotypic interactions with leukocytes. However, these mechanisms in the context of chronic liver disease are poorly understood and have been studied mainly in mice.
Our working model is that platelets docked in the liver of NAFLD patients amplify the inflammatory state by releasing pro-inflammatory cytokines, 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 and progression to NASH. In this context the investigators expect to identify an important role of GPVI and CLEC-2 and their inhibitory counterparts PECAM-1 and TLT-1, which are critically implicated in the regulation of platelet activation at sites of inflammation.
The investigators anticipate that features of the platelet inflammatory response could be both sensitive and sex-specific biomarkers for NASH progression and novel therapeutic targets.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NASH GROUP | – | Other: High fat meal in a subset of patients with NAFL or NASHRecruited (n=22) patients with non-alcoholic steatohepatitis. |
| NAFL GROUP | – | Other: High fat meal in a subset of patients with NAFL or NASHRecruited (n=22) patients with non-alcoholic fatty liver. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Written informed consent
- Both sexes
- Patients with NAFL and NASH according to EASL Guidelines 2016.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| High fat meal in a subset of patients with NAFL or NASHIn 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. | Other | NAFL GROUP, NASH GROUP |
Primary outcome
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
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 42817874Maiorca F, Sabetta A, Sangineto M, Pallucci D, Dufies O, Poli V, Di Gioia M, D'Amico T, Miglionico M, Lombardi L, Ciarnelli M, Signorile G, D'Amati G, Romiti GF, Cangemi R, Visentini M, Raparelli V, Serviddio G, Basili S, Zanoni I, Stefanini L; Precision Medicine Liver Group. Hypermetabolic State Drives Platelet Dysfunction in Human and Mouse Metabolic Dysfunction-Associated Steatotic Liver Disease. Arterioscler Thromb Vasc Biol. 2026 Oct 1. doi: 10.1161/ATVBAHA.126.325001. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
STEFANIA BASILI, MD principal investigator
SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Stefania Basili at 2 sites 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 4 inclusion and 6 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Lucia Stefanini, PhD (+390649972018, lucia.stefanini@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128253, which also lists 1 linked publication.
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 13 Jan 2022.