Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors

Serum concentrations of liver enzymes-aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT)-were measured via standard venous blood sampling (liver function test) and reported in units per liter (U/L). Elevated levels of these enzymes typically indicate liver inflammation or hepatocellular injury. Data represent the change from baseline (post-treatment value minus baseline value) at the designated time point. A greater negative change (reduction in enzyme levels) reflects an improvement in liver function.

Transient elastography (FibroScan) is a non-invasive ultrasound examination evaluating hepatic steatosis (fatty liver) and fibrosis (scarring). Controlled Attenuation Parameter (CAP), measured in dB/m, quantifies liver fat. Liver Stiffness Measurement (LSM), measured in kPa, assesses tissue stiffness. Data represent the change from baseline (post-treatment minus baseline). Negative changes in both scores indicate reductions in liver fat and stiffness, representing improved liver outcomes.

Living donor liver transplantation (LDLT) is a surgical procedure in which a healthy individual donates a portion of their liver to a recipient with liver disease. Candidates with hepatic steatosis (fatty liver) typically undergo medical evaluation and intervention to reduce liver fat to safe levels prior to donation. This outcome measure evaluates whether participating potential donors successfully proceeded to the surgical donation following protocol completion. The data represent the percentage of enrolled participants who completed living liver donation, confirmed via medical and surgical records at the study endpoint. Higher percentages reflect higher donor eligibility and successful procedure rates.

Time to living liver donation was defined as the duration (in days) from the date of study enrollment to the date of the donor hepatectomy surgery for living donor liver transplantation (LDLT). The exact surgical date was confirmed through hospital electronic medical records. For participants who did not proceed to donation due to withdrawal, ineligibility, or study completion without surgery, data were censored at the date of the last follow-up visit. The reported data represent the median time required for potential donors to achieve eligibility and undergo the donation procedure, where shorter durations reflect more rapid donor readiness.

Body weight was measured in kilograms using a standardized calibrated digital scale, and body mass index (BMI) was calculated as body weight in kilograms divided by the square of height in meters (kg/m²). Percentage reduction from baseline was calculated as: [(Baseline Value - Post-treatment Value) / Baseline Value] × 100. A reduction of at least 10% in body weight typically corresponds to an equivalent percentage reduction in BMI. The reported data represent the percentage of participants who achieved a reduction of 10% or greater from baseline at the designated evaluation time point. Higher percentages indicate a greater proportion of participants achieving clinically significant weight and BMI reduction.

Body weight was measured in kilograms (kg) using a calibrated digital scale, and body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). Data represent the change from baseline (post-treatment value minus baseline value) at the designated evaluation time point. A negative change reflects a reduction in body weight and BMI, indicating successful weight loss.

The Fibrosis-4 (FIB-4) index is a non-invasive scoring system used to estimate the risk of liver fibrosis (scarring). The score is calculated using standard clinical parameters. Data represent the change from baseline (post-treatment score minus baseline score) at the designated evaluation time point. Lower scores reflect a lower probability of advanced fibrosis, and a negative change from baseline indicates an improvement in liver fibrosis status.

Comorbid conditions-hypertension (high blood pressure), diabetes mellitus (elevated blood glucose), and dyslipidemia (abnormal blood lipid levels)-were assessed at baseline and the designated follow-up visit using standardized blood pressure measurements, fasting blood glucose or glycated hemoglobin (HbA1c) levels, and serum lipid panels. Improvement was defined as achieving clinically recommended target ranges (e.g., blood pressure <130/80 mmHg, HbA1c <6.5%, or normalized lipid profiles) or a documented reduction or discontinuation in related prescription medications without disease worsening. The reported data represent the number of participants who demonstrated improvement in one or more of these baseline comorbidities. Higher numbers reflect more favorable cardiometabolic health outcomes.