Influence of Donor and Recipient Genetic Polymorphisms on Graft Steatosis After Liver Transplant

NCT07685353 | Recruiting

• 1 other identifier: IEC/2024/108/MA10
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Liver Disease and Cirrhosis

Outcome Measures

Primary Outcomes (1)

• PNPLA3 and MBOAT7 gene polymorphisms

  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

  3 years after Liver Transplantation

Study Arms (1)

Chronic Liver Disease

Chronic Liver Disease patients undergoing Living Donor Liver Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Pediatric (\<18 years)
• Transplants for ALF/ ACLF

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, India

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Viniyendra Pamecha, MS, FEBS

  Institute of Liver and Biliary Sciences

  STUDY DIRECTOR

Central Study Contacts

Naren Mandalapu, MS

CONTACT

+918096006447; bearebel69@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-06

Locations

IN (1)