Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors

Liver Insufficiency Clinical Trial

Official title:

Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922323
• Other study ID #: 013-140
• Status: Completed
• Phase: N/A
• First received: August 12, 2013
• Last updated: March 27, 2017
• Start date: August 2013
• Est. completion date: September 26, 2016

Study information

• Verified date: March 2017
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 26, 2016
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Insufficiency

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterized Metabolic Changes during liver regeneration		one year after donation