Fecal Microbiota Analysis of PNPLA3 Polymorphism in Hispanic Patients With MASLD
NCT ID: NCT06495333
Last Updated: 2024-07-10
Study Results
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Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-07-05
2025-08-20
Brief Summary
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Detailed Description
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A multi-hit model has been proposed that most accurately describes both the development of simple steatosis and its transition from simple steatosis to progressive stages of the disease. In this model, a close interaction between dietary, environmental, and genetic factors with insulin resistance, lipotoxicity, and fat metabolism comprises multiple insults acting together on predisposed subjects to induce MASLD. This model has led to the understanding that the interplay between diet, genetics, and gut microbiota is of utmost importance in the development and progression of the condition. As a multi-factorial disease, assigning specific disease pathways to the overall phenotype has been challenging. Still, it is important to investigate associations between its risk factors to direct therapeutic interventions to the most relevant pathways.
Looking at two of the most relevant risk factors, this study aims to investigate whether there are any differences in the taxonomic composition of the gut microbiota between Hispanic patients with MASLD with different PNPLA3 genotypes. The PNPLA3 (patatin-like phospholipase domain-containing protein 3) polymorphism has been implicated in the pathogenesis and progression of the condition. However, the role of PNPLA3 polymorphism in shaping the fecal microbiota composition in Hispanic patients with MASLD remains unclear. Once fecal and blood samples are collected from a cohort of Hispanic individuals with MASLD, fecal microbiota sequencing and PNPLA3 genotyping will be done. Findings will reveal whether there are significant alterations in the fecal microbiota composition in relation to PNPLA3 polymorphism in Hispanic patients with MASLD. Results could provide evidence for a potential link between PNPLA3 polymorphism and fecal microbiota composition in Hispanic individuals with MASLD.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Patient must be of Hispanic ethnicity residing in Puerto Rico. Age 21 to 75 years old at time of informed consent. Evidence of MASLD by vibration-controlled transient elastography (FibroScan) controlled attenuation parameter (CAP) (value must be greater than or equal to 248 dB/m).
Willing and able to provide informed consent signed by study subject. Willing and able to understand and complete study-related procedures.
Exclusion Criteria
Excessive alcohol intake for ≥3 months during past year prior to screening (\>3 units/day for males and \>2 units/day for female is generally considered excessive).
History of liver transplant, or current placement on a liver transplant list. History of viral and resolved hepatitis (Hepatitis B or C) or human immunodeficiency virus (HIV).
Use of antibiotics within 14 days of screening.
21 Years
75 Years
ALL
No
Sponsors
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Fundacion de Investigacion Science and Education
OTHER
Responsible Party
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Principal Investigators
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Andrea Pi, BS
Role: STUDY_CHAIR
FDI Clinical Research
Locations
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FDI Clinical Research
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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References
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Buzzetti E, Pinzani M, Tsochatzis EA. The multiple-hit pathogenesis of non-alcoholic fatty liver disease (NAFLD). Metabolism. 2016 Aug;65(8):1038-48. doi: 10.1016/j.metabol.2015.12.012. Epub 2016 Jan 4.
Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi: 10.7570/jomes23052. Epub 2023 Sep 13.
Godoy-Matos AF, Silva Junior WS, Valerio CM. NAFLD as a continuum: from obesity to metabolic syndrome and diabetes. Diabetol Metab Syndr. 2020 Jul 14;12:60. doi: 10.1186/s13098-020-00570-y. eCollection 2020.
Lang S, Martin A, Zhang X, Farowski F, Wisplinghoff H, J G T Vehreschild M, Krawczyk M, Nowag A, Kretzschmar A, Scholz C, Kasper P, Roderburg C, Mohr R, Lammert F, Tacke F, Schnabl B, Goeser T, Steffen HM, Demir M. Combined analysis of gut microbiota, diet and PNPLA3 polymorphism in biopsy-proven non-alcoholic fatty liver disease. Liver Int. 2021 Jul;41(7):1576-1591. doi: 10.1111/liv.14899. Epub 2021 May 7.
Tilg H, Adolph TE, Moschen AR. Multiple Parallel Hits Hypothesis in Nonalcoholic Fatty Liver Disease: Revisited After a Decade. Hepatology. 2021 Feb;73(2):833-842. doi: 10.1002/hep.31518. Epub 2021 Feb 6. No abstract available.
Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet. 2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25.
Related Links
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New MASLD Nomenclature
Nonalcoholic Fatty Liver Disease (NAFLD)
Fatty liver disease diet: What foods help prevent and reverse fatty liver?.
Non-Alcoholic Fatty Liver Disease: Assessment and Management.
Other Identifiers
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FDI-2024-001
Identifier Type: -
Identifier Source: org_study_id
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