Overview

This trial is active, not recruiting.

Condition liver insufficiency
Sponsor Baylor Research Institute
Start date August 2013
End date August 2018
Trial size 20 participants
Trial identifier NCT01922323, 013-140

Summary

The PI will study metabolism during liver regeneration in living liver donors

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Characterized Metabolic Changes during liver regeneration
time frame: one year after donation

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Potential donor must be in excellent medical and psychological health. 2. Potential donor must be between the ages of 18 and 60. 3. Must have a compatible blood type to the recipient. 4. Must have health care coverage for non-donor related health issues that arise post donation 5. Recipient and donor must have compatible body size. 6. Donors Body Mass Index (BMI) must be less than 30. 7. All previous donor abdominal surgeries will be reviewed on a case by case basis by the surgeon. Exclusion Criteria: 1. Positive blood test for Human Immunodeficiency Virus, Hepatitis C virus, Hepatitis B virus 2. The size of the donor liver is not large enough to safely resection and still retain enough volume to function normally after the surgery. 3. Liver biopsy show liver cirrhosis or early stages of HCC.

Additional Information

Official title Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
Principal investigator Giuliano Testa, MD
Description Samples of blood and urine will be collected from study participants at defined timepoints. The samples will be evaluated to study the metabolism of the regenerating liver after a portion of the liver has been donated from a living donor.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Baylor Research Institute.