Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
NCT07922720, Not applicable, Not yet recruiting, Samsung Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors | ClinicalTrials.gov |
| NCT number | NCT07922720 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Samsung Medical Center | ClinicalTrials.gov |
| Conditions | Hepatic Steatosis, Fatty Liver, Non-Alcoholic Fatty Liver Disease, Metabolic Dysfunction-Associated Steatotic Liver Disease, Living Donors | ClinicalTrials.gov |
| Interventions | GODEX® capsule treatment group | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of Participants With Liver-to-spleen Attenuation Difference Greater Than 10 Hounsfield Units (HU) or Absolute Liver Attenuation Greater Than 40 HU on Liver Computed Tomography (CT) | Baseline (Preoperative) | Non-contrast liver computed tomography (CT) was performed to assess hepatic steatosis (fatty liver). Tissue radiodensity was measured in Hounsfield Units (HU) in the liver and spleen. The data represent the percentage of participants who achieved a liver-to-spleen attenuation difference greater than 10 HU or an absolute liver attenuation greater than 40 HU, indicating significant reduction or resolution of liver fat. Higher percentages represent better outcomes. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Serum Concentrations of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Gamma-Glutamyl Transferase (GGT) | Baseline and 36 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) Assessed by Transient Elastography (FibroScan) | Baseline and 36 weeks | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants Who Successfully Underwent Living Donor Liver Transplantation (LDLT) | Baseline and 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Time to Living Liver Donation From Study Enrollment | Baseline and 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With at Least a 10 Percent Reduction in Body Weight and Body Mass Index (BMI) | Baseline and 36 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Body Weight and Body Mass Index (BMI) | Baseline and 36 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Fibrosis-4 (FIB-4) Index Scores | Baseline and 36 weeks | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants With Improvement in Comorbidities: Hypertension, Diabetes Mellitus, and Dyslipidemia | Baseline and 36 weeks | 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. | ClinicalTrials.gov |
| Other | Number of Participants and Incidence of Adverse Events (AEs) Stratified by Severity, Causality, and System Organ Class (SOC) Using the Medical Dictionary for Regulatory Activities (MedDRA) | Through study completion, an average of 36 weeks | An adverse event (AE) is defined as any untoward medical occurrence in a participant, regardless of whether it is considered related to the study intervention. AEs were monitored through participant self-reports, physical examinations, and clinical laboratory evaluations throughout the study period. All reported events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) and classified by System Organ Class (SOC) and Preferred Term (PT). Each event was assessed for severity (mild, moderate, or severe), causality (related or not related to the study intervention), actions taken (e.g., dose modification or discontinuation), and clinical outcome (e.g., resolved or persistent). Reported data include the total number of events, the number of participants experiencing at least one event, and the corresponding percentages within each category. Lower incidences reflect a more favorable safety profile. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
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Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)