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NCT07922720
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Conditions: Hepatic Steatosis, Fatty Liver, Non-Alcoholic Fatty Liver Disease, Metabolic Dysfunction-Associated Steatotic Liver Disease, Living Donors
Sex: All
Ages: 19 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Samsung Medical Center
Summary
Living donor liver transplantation (LDLT) is a critical therapeutic modality for patients with end-stage liver disease and hepatic malignancies. However, the donor's surgical safety is paramount, and the presence of hepatic steatosis frequently precludes potential donors from qualifying for donation due to risks for both donor and recipient. With the rising prevalence of fatty liver disease, an increasing number of candidate donors are excluded during screening, complicating timely transplantation for urgent recipients.
This study aims to evaluate whether the administration of a carnitine complex (GODEX®) can improve hepatic steatosis within 3 months, as assessed by liver computed tomography (CT), in potential living liver donors. In addition, the study will investigate the living liver donation rate within 3 months, post-enrollment donor liver function at 36 weeks, weight and BMI reduction, and improvements in associated metabolic comorbidities (hypertension, diabetes mellitus, and dyslipidemia).
Eligibility Criteria
Inclusion Criteria:
1. Living liver donors diagnosed with hepatic steatosis (or fatty liver)
2. Living liver donors with a liver-to-spleen attenuation difference of \
Source: ClinicalTrials.gov (NCT07922720). StuddyBuddy aggregates publicly available trial information.