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- Ensaio Clínico NCT07685353
Influence of Donor and Recipient Genetic Polymorphisms on Graft Steatosis After Liver Transplant
Influence of Donor and Recipient PNPLA3 and MBOAT7 Gene Polymorphisms on Graft Liver Steatosis After Living Donor Liver Transplant for Metabolic Dysfunction-associated Steatohepatitis (MASH) Related Cirrhosis
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to shape disease susceptibility and progression.
Genetic and epidemiological studies, indicates strong heritability of hepatic fat content.Family studies demonstrate that first degree relatives of patients with MAFLD are at a much higher risk of the disease than the general population.Most of the data available is regarding Deceased Donor Liver Transplant and Western population.Most studies have studied single gene variant but fatty liver is a polygenic trait.No study was done exclusively in MASH recipients.
In this study we aim to study the effect of recipient and donor PNPLA3, MBOAT7 gene variations, and other clinical & laboratory data on graft liver steatosis in liver transplant recipients. We also propose to compare the outcomes of genetically related donors vs unrelated donors, to know the influence of genetic factors vis-a-vis environmental factors.
Visão geral do estudo
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Condições
Descrição detalhada
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to shape disease susceptibility and progression.
Genetic and epidemiological studies, indicates strong heritability of hepatic fat content.Family studies demonstrate that first degree relatives of patients with MAFLD are at a much higher risk of the disease than the general population.
PNPLA3 isoleucine to methionine substitution at position 148 is the most robust and well replicated genetic variant associated with MAFLD. MBOAT7 was recently associated with the risk of MAFLD, inflammation and fibrosis. Furthermore, it was recently linked to progression of MAFLD to HCC.
Most of the data available on donor and recipient PNPLA3 and MBOAT7 gene polymorphisms is with regards to Deceased Donor Liver Transplant and Western population. There are contradictory conclusions in different studies. Most studies have studied single gene variant but MAFLD is a polygenic trait. No study exclusively in MASH related CLD recipients. A study in the setting of LDLT gives us an opportunity to assess both genotypic and phenotypic (environmental) factors. Hence this study is being done in a high volume liver transplant center in India, in the setting of LDLT which gives us an opportunity to assess both genotypic and phenotypic (environmental) factors.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Naren Mandalapu, MS
- Número de telefone: +918096006447
- E-mail: bearebel69@gmail.com
Locais de estudo
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New Delhi, Índia
- Recrutamento
- Institute of liver and Biliary Sciences
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Contato:
- Naren Mandalapu, MS
- Número de telefone: +918096006447
- E-mail: bearebel69@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- All LDLT recipients with MASH related CLD and their donors who underwent their surgery at ILBS at least 3 years prior to the onset of this study.
Exclusion Criteria:
- Pediatric (<18 years)
- Transplants for ALF/ ACLF
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Chronic Liver Disease
Chronic Liver Disease patients undergoing Living Donor Liver Transplantation
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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PNPLA3 and MBOAT7 gene polymorphisms
Prazo: 3 years after Liver Transplantation
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To assess the impact of donor and recipient PNPLA3 and MBOAT7 gene polymorphisms on the development and severity of graft steatosis following Living Donor Liver Transplantation
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3 years after Liver Transplantation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Viniyendra Pamecha, MS, FEBS, Institute of liver and Biliary Sciences
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IEC/2024/108/MA10
Plano para dados de participantes individuais (IPD)
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