Non-Alcoholic Fatty Liver DiseaseNAFLD LALNCT05419765
Lysosomal Acid Lipase Activity in Nonalcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is a multifactorial disease affecting a quarter of the world population. Pathological accumulation of fat, into the hepatocytes, is the first hit and is due to altered hepatic and extrahepatic lipogenesis, lipolysis and lipophagy of the large lipid droplets. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Peripheral blood withdrawn
- How many people
- 316 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to 31 Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-cirrhotic NALFD patients, wild type for the PNPLA3 risk variant and with a LAL value in DBS of 0.88±0.38 (mean±SD) and non-cirrhotic NALFD patients, carriers for PNPLA3 risk variant (heterozygous and mutant homozygous both) with a LAL value in DBS of 0.76±0.38 (mean±SD)
Who may be able to join
- Caucasian Italian subjects
- age > 18 and < 70 years
- non-cirrhotic NAFLD
Who cannot join
- any malignant disease during the last 5 years
- any inflammatory or autoimmune disease
- corticosteroids for systemic use
- any medication potentially affecting body weight or body composition
- syndromic obesity
- renal failure (GFR<90 ml/min)
Show all 13Show fewer
- heart failure (NYHA classes II-IV)
- any type liver disease rather than NAFLD
- alcohol intake >140g/ week for men and 70g/ week for women
- participation in a reducing- weight program in the last 3 months
- cholestyramine during the last 6 months before enrollment
- previous cholecystectomy
- gallbladder disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Translational and Precision Medicine, Sapienza University of Rome, Umberto I Hospital
Rome, Rome, 00185
About this study
Official title: Nonalcoholic Fatty Liver Disease: Crosstalk Between Genetic Predisposition and Epigenetic Lysosomal Acid Lipase Activity Reduction in Blood, Plasma and Platelets
Non-alcoholic fatty liver disease (NAFLD) is a multifactorial disease affecting a quarter of the world population. Pathological accumulation of fat, into the hepatocytes, is the first hit and is due to altered hepatic and extrahepatic lipogenesis, lipolysis and lipophagy of the large lipid droplets.
Lipophagy plays a key role in the onset of NAFLD, in the autolysosomes, small droplets of fat are catabolized by Lysosomal Acid Lipase (LAL) enzyme which hydrolyzes cholesterol esters and triglycerides forming cholesterol and free fatty acids.
Read more
Our research group demonstrated that, subjects affected by NAFLD, present a reduced enzymatic activity either compared to patients with chronic liver disease of different etiology, but comparable staging, either compared to healthy control subjects.
Leukocytes are the main site of enzymatic activity in the blood, however, our research group has shown that it can also be detected inside the platelets, demonstrating how the LAL activity can be exchanged between cells.
Furthermore, our group has shown, for the first time, how the intracellular enzymatic activity is reduced, independently of the platelets and leukocytes count and progressively from chronic liver disease up to cirrhosis.
Among factors which contribute to altered lipid metabolism, the genetic predisposition to the accumulation of hepatic fat must be counted. Several variants of genes that code for proteins implicated in the digestion or storage of fats, are involved.
In this study were considered: patatin-like phospholipase domain-containing 3 (PNPLA3), Transmembrane 6 superfamily 2 (TM6SF2) and 17β-Hydroxysteroid dehydrogenase type 13 (HSD17B13).
The rs738409 variant (C> G, p.I148M) of the PNPLA3 gene consists of a protein in which the catalytic site is not entirely accessible to the substrate which, consequently, accumulates in the storage site.
This variant is commonly found in NAFLD subjects and it has been widely reported how the variant carriers progress faster towards severe disease (steatohepatitis) than wild type subjects.
The TM6SF2 gene encodes a membrane transporter involved in the triglycerides movement, the rs58542926 (C> T E167K) variant has been associated with an increased predisposition towards liver fibrosis in NAFLD subjects. This is likely due to the loss of protein function resulting in hepatic retention of triglycerides and cholesterol.
Unlike PNPLA3 and TM6SF2, the rs72613567 (TA> TAA) variant of the HSD17B13 gene has a protective effect against NAFLD progression. It is characterized by a protein loss of function that protects against chronic liver damage and mitigates the progression of the disease although how the protective effect occurs is still under study.
Due to the multifactorial etiology of the disease, to the need of carrying out a targeted surveillance in predisposed genetic subjects and, in order to prevent NALFD progression towards severe pathological forms characterized by an increased mortality, in this study, 316 subjects will be enrolled.
They will be divided as follows: Italian Caucasians, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the PNPLA3 I148M variant, and, 158 Italian Caucasian subjects, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the wild type allele.
The following exclusion criteria will be considered: any type of malignant disease in the past 5 years, any type of inflammatory or autoimmune disease, corticosteroids for systemic use, any type of drug that may affect body weight or body composition, insufficiency kidney (GFR <90 mL / min), heart failure (NYHA classes II-IV), any type of liver disease rather than NAFLD, excessive alcohol intake (> 140 g / week for men and 70 g / week for women), participation in a weight reduction program in the past 3 months, bile salts, cholestyramine in the last 6 months prior to enrollment, previous cholecystectomy, gallbladder disease.
Peripheral blood will be withdrawn in order to measure haematic lipids (total cholesterol and fractions, triglycerides), total blood LAL activity, to perform genetic analysis and finally to evaluate lipase activity into the platelets.
Hepatic elastography will be also executed, in 100 patients, according to the presence/absence of the PNPLA3 variant, in order to weigh up the genetic predisposition on NAFLD development or progression Finally, in subjects who present a lipase activity 30% lower than the normal value (0.88 ± 0.38 (mean ± SD), the methylation of the LIPA promoter will be studied.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Peripheral blood withdrawn
- Keywords
- Lysosomal acide lipase, PNPLA3, TM6SF2, HSD17B13, Hepatic elastography
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood withdrawnDiagnostic test
Also called Hepatic elastography
Peripheral blood will be withdrawn in order to measure haematic lipids (total cholesterol and fractions, triglycerides), total blood LAL activity, to perform genetic analysis and finally to evaluate lipase activity into the platelets.
Hepatic elastography will be also executed, in 100 patients, according to the presence/absence of the PNPLA3 variant, in order to weigh up the genetic predisposition on NAFLD development or progression
| Study group | Role | What they receive |
|---|---|---|
| non-cirrhotic NAFLD, carriers of the PNPLA3 I148M variant | Italian Caucasians, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the PNPLA3 I148M variant Receives: Diagnostic Test: Peripheral blood withdrawn | |
| non-cirrhotic NAFLD, carriers of the wild type allele | Italian Caucasian subjects, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the wild type allele Receives: Diagnostic Test: Peripheral blood withdrawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition enzyme assay to test LAL activity
Activity of LAL enzyme will be measured in 158 subjects affected by non-cirrhotic NAFLD and wild type for the PNPLA3 rs738409 risk variant, in whole blood, plasma and platelets.
Measured: enrollment
Inhibition enzyme assay to test LAL activity
Activity of LAL enzyme will be measured in 158 subjects affected by non-cirrhotic NAFLD and carriers for the PNPLA3 rs738409 risk variant, in whole blood, plasma and platelets.
Measured: enrollment
Secondary outcomes (2)
Inhibition enzyme assay to test LAL activity variation
Activity of LAL enzyme will be measured at 18 months respect to enrollment, in 158 subjects affected by non-cirrhotic NAFLD and wild type for the PNPLA3 rs738409 risk variant, in whole blood, plasma and platelets.
Measured: 18 months
Inhibition enzyme assay to test LAL activity variation
Activity of LAL enzyme will be measured at 18 months respect to enrollment, in 158 subjects affected by non-cirrhotic NAFLD and carriers for the PNPLA3 rs738409 risk variant, in whole blood, plasma and platelets.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Mar 2022
- Primary completion31 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, STEFANO GINANNI CORRADINI, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419765
- Sponsor's protocol ID
- Sapienza Univ&Alexion Pharma
- Acronym
- NAFLD LAL
- Status last verified
- Mar 2022
- First submitted
- 26 May 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonalcoholic Fatty Liver Disease: Crosstalk Between Genetic Predisposition and Epigenetic Lysosomal Acid Lipase Activity Reduction in Blood, Plasma and Platelets
- ClinicalTrials.gov ID
- NCT05419765
- Acronym / sponsor ID
- NAFLD LAL / Sapienza Univ&Alexion Pharma
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Lysosomal acide lipase, PNPLA3, TM6SF2, HSD17B13, Hepatic elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 15 Jun 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.
Non-alcoholic fatty liver disease (NAFLD) is a multifactorial disease affecting a quarter of the world population. Pathological accumulation of fat, into the hepatocytes, is the first hit and is due to altered hepatic and extrahepatic lipogenesis, lipolysis and lipophagy of the large lipid droplets.
Lipophagy plays a key role in the onset of NAFLD, in the autolysosomes, small droplets of fat are catabolized by Lysosomal Acid Lipase (LAL) enzyme which hydrolyzes cholesterol esters and triglycerides forming cholesterol and free fatty acids.
Our research group demonstrated that, subjects affected by NAFLD, present a reduced enzymatic activity either compared to patients with chronic liver disease of different etiology, but comparable staging, either compared to healthy control subjects.
Leukocytes are the main site of enzymatic activity in the blood, however, our research group has shown that it can also be detected inside the platelets, demonstrating how the LAL activity can be exchanged between cells.
Furthermore, our group has shown, for the first time, how the intracellular enzymatic activity is reduced, independently of the platelets and leukocytes count and progressively from chronic liver disease up to cirrhosis.
Among factors which contribute to altered lipid metabolism, the genetic predisposition to the accumulation of hepatic fat must be counted. Several variants of genes that code for proteins implicated in the digestion or storage of fats, are involved.
In this study were considered: patatin-like phospholipase domain-containing 3 (PNPLA3), Transmembrane 6 superfamily 2 (TM6SF2) and 17β-Hydroxysteroid dehydrogenase type 13 (HSD17B13).
The rs738409 variant (C> G, p.I148M) of the PNPLA3 gene consists of a protein in which the catalytic site is not entirely accessible to the substrate which, consequently, accumulates in the storage site.
This variant is commonly found in NAFLD subjects and it has been widely reported how the variant carriers progress faster towards severe disease (steatohepatitis) than wild type subjects.
The TM6SF2 gene encodes a membrane transporter involved in the triglycerides movement, the rs58542926 (C> T E167K) variant has been associated with an increased predisposition towards liver fibrosis in NAFLD subjects. This is likely due to the loss of protein function resulting in hepatic retention of triglycerides and cholesterol.
Unlike PNPLA3 and TM6SF2, the rs72613567 (TA> TAA) variant of the HSD17B13 gene has a protective effect against NAFLD progression. It is characterized by a protein loss of function that protects against chronic liver damage and mitigates the progression of the disease although how the protective effect occurs is still under study.
Due to the multifactorial etiology of the disease, to the need of carrying out a targeted surveillance in predisposed genetic subjects and, in order to prevent NALFD progression towards severe pathological forms characterized by an increased mortality, in this study, 316 subjects will be enrolled.
They will be divided as follows: Italian Caucasians, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the PNPLA3 I148M variant, and, 158 Italian Caucasian subjects, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the wild type allele.
The following exclusion criteria will be considered: any type of malignant disease in the past 5 years, any type of inflammatory or autoimmune disease, corticosteroids for systemic use, any type of drug that may affect body weight or body composition, insufficiency kidney (GFR <90 mL / min), heart failure (NYHA classes II-IV), any type of liver disease rather than NAFLD, excessive alcohol intake (> 140 g / week for men and 70 g / week for women), participation in a weight reduction program in the past 3 months, bile salts, cholestyramine in the last 6 months prior to enrollment, previous cholecystectomy, gallbladder disease.
Peripheral blood will be withdrawn in order to measure haematic lipids (total cholesterol and fractions, triglycerides), total blood LAL activity, to perform genetic analysis and finally to evaluate lipase activity into the platelets.
Hepatic elastography will be also executed, in 100 patients, according to the presence/absence of the PNPLA3 variant, in order to weigh up the genetic predisposition on NAFLD development or progression Finally, in subjects who present a lipase activity 30% lower than the normal value (0.88 ± 0.38 (mean ± SD), the methylation of the LIPA promoter will be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-cirrhotic NAFLD, carriers of the PNPLA3 I148M variant | – | Diagnostic Test: Peripheral blood withdrawnItalian Caucasians, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the PNPLA3 I148M variant |
| non-cirrhotic NAFLD, carriers of the wild type allele | – | Diagnostic Test: Peripheral blood withdrawnItalian Caucasian subjects, aged> 18 and <70 years, with non-cirrhotic NAFLD and carriers of the wild type allele |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-cirrhotic NALFD patients, wild type for the PNPLA3 risk variant and with a LAL value in DBS of 0.88±0.38 (mean±SD) and non-cirrhotic NALFD patients, carriers for PNPLA3 risk variant (heterozygous and mutant homozygous both) with a LAL value in DBS of 0.76±0.38 (mean±SD)
Key inclusion criteria (3 listed)
- Caucasian Italian subjects
- age > 18 and < 70 years
- non-cirrhotic NAFLD
Key exclusion criteria (13 listed)
- any malignant disease during the last 5 years
- any inflammatory or autoimmune disease
- corticosteroids for systemic use
- any medication potentially affecting body weight or body composition
- syndromic obesity
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 |
|---|---|---|
| Peripheral blood withdrawnAlso: Hepatic elastographyPeripheral blood will be withdrawn in order to measure haematic lipids (total cholesterol and fractions, triglycerides), total blood LAL activity, to perform genetic analysis and finally to evaluate lipase activity into the platelets. Hepatic elastography will be also executed, in 100 patients, according to the presence/absence of the PNPLA3 variant, in order to weigh up the genetic predisposition on NAFLD development or progression | Diagnostic test | non-cirrhotic NAFLD, carriers of the PNPLA3 I148M variant, non-cirrhotic NAFLD, carriers of the wild type allele |
Primary outcome
Inhibition enzyme assay to test LAL activity
Time frame: enrollment
Activity of LAL enzyme will be measured in 158 subjects affected by non-cirrhotic NAFLD and wild type for the PNPLA3 rs738409 risk variant, in whole blood, plasma and platelets.
Inhibition enzyme assay to test LAL activity
Time frame: enrollment
Activity of LAL enzyme will be measured in 158 subjects affected by non-cirrhotic NAFLD and carriers for the PNPLA3 rs738409 risk variant, in whole blood, plasma and platelets.
2 secondary outcomes
Inhibition enzyme assay to test LAL activity variation
Time frame: 18 months
Inhibition enzyme assay to test LAL activity variation
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non-Alcoholic Fatty Liver Disease, run by University of Roma La Sapienza 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 9 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition enzyme assay to test LAL activity (time frame: enrollment). The study lists 2 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 9 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.