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

March 27, 2017 updated by: Baylor Research Institute
The PI will study metabolism during liver regeneration in living liver donors

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be comprised of living liver donors.

Description

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterized Metabolic Changes during liver regeneration
Time Frame: one year after donation
one year after donation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Giuliano Testa, MD, Sammons Cancer Center, Baylor University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 26, 2016

Study Completion (Actual)

September 26, 2016

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013-140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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