Non-Alcoholic Fatty Liver Disease Clinical Trials

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Targeting the Epigenetic Regulators Suv420h1/2 in Hepatocytes to Treat Nonalcoholic Fatty Liver Disease

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ We will analyse data and samples from subjects with the following criteria:

• Subjects aged\>18;

• Subjects who have already given their consent to genetic analysis and whose samples and data have already been collected as part of the SERENA, REASON and MAFALDA studies;

• Subjects who have given their consent to participate in this study.

⁃ In particular, subjects with the following characteristics were included respectively:

• in the SERENA study:

‣ Diagnosis of NAFLD

⁃ Age between 45 and 75 years old

⁃ Any of the following criteria:

• F3-F4 fibrosis, determined histologically, or by non-invasive techniques, or evidence of cirrhosis deriving from biochemical tests or imaging methods;

∙ Family history of related first-degree primary liver cancer, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT)

∙ Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.

• in the REASON study:

⁃ Patients aged\>18, who have given their consent to participate in the study, who underwent the fol- lowing procedures:

• liver biopsy for suspected non-alcoholic steatohepatitis (NASH) at the time of diagnosis;

• liver resection for hepatocarcinoma, other liver lesions (including secondaries from other neo- plasms and benign focal lesions, which will allow obtaining healthy starting liver tissue), biopsies of whole liver explants obtained at the time of liver transplantation AND cholecystectomies.

• In the MAFALDA study:

⁃ Patients undergoing bariatric surgery for grade 3 obesity (BMI ≥40 Kg/m2) or grade 2 obesity plus:

• metabolic comorbidities (uncontrolled hypertension, diabetes, dyslipidemia);

• lack of contraindication to surgery (e.g. advanced liver disease with portal hypertension);

• willingness to sign an informed consent.

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
RECRUITING
Milan
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 260
Treatments
Experimental: the main genes and expression by comparing the transcriptomic lipidomic profile
To identify the main genes and pathways differentially expressed and the main factors associ- ated with SUV420H1/H2 expression by comparing the transcriptomic and lipidomic profile of indi- viduals with low hepatic SUV420H1/H2 mRNA expression levels (lowest expression quartile) to that from individuals with high expression levels (top quartile).~In order to evaluate the role of SUV420H1/H2 in the regulation of gene expression in NAFLD pa- tients, we will exploit already available transcriptomic and lipidomic data by analyzing the gene ex- pression databases deriving from ongoing studies conducted at the Fondazione and by the PI of the Catanzaro collaborating centre. Data have been generated from liver and visceral adipose biopsy of obese individuals at high risk of developing NASH (SERENA Study at Fondazione, and MAFALDA Study, coordinated by prof Stefano Romeo, PI of the Università Magna Graecia Catanzaro).
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov