Investigating the role of SUV420H1/2 in liver cells for treating fatty liver disease
Targeting the Epigenetic Regulators Suv420h1/2 in Hepatocytes to Treat Nonalcoholic Fatty Liver Disease
This study is testing if turning off certain genes in liver cells can help protect people from nonalcoholic fatty liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06332677 on ClinicalTrials.gov |
What this trial studies
This study focuses on nonalcoholic fatty liver disease (NAFLD), a leading cause of liver disease that can progress to serious conditions like cirrhosis and liver cancer. The research aims to explore the role of the epigenetic factors SUV420H1/2 in liver cells, particularly how their inactivation may protect against NAFLD. The methodology includes evaluating genetic deletions in mice and analyzing human liver transcriptomic data to assess the relevance of these findings. Additionally, the study will investigate the potential of using antisense oligonucleotides to target and downregulate SUV420H1/2 as a therapeutic approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 45 to 75 with a diagnosis of NAFLD and specific fibrosis criteria or risk factors.
Not a fit: Patients without a diagnosis of NAFLD or those under 45 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new therapeutic strategies for treating NAFLD and preventing its progression to more severe liver diseases.
How similar studies have performed: While the specific approach of targeting SUV420H1/2 is novel, other studies have shown promise in exploring epigenetic factors in liver diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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:
1. Diagnosis of NAFLD
2. Age between 45 and 75 years old
3. Any of the following criteria:
1. F3-F4 fibrosis, determined histologically, or by non-invasive techniques, or evidence of cirrhosis deriving from biochemical tests or imaging methods;
2. 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)
3. 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.
Exclusion Criteria:
* Individuals not reporting one of the inclusion criteria listed above or reporting at-risk alcohol intake (\>30/20 g/day in M/F), viral and autoimmune hepatitis or other causes of liver disease will be ex- cluded.
Where this trial is running
Milan
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica — Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.