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

NCT ID: NCT01922323

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-09-26

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Insufficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuliano Testa, MD

Role: PRINCIPAL_INVESTIGATOR

Sammons Cancer Center, Baylor University Medical Center

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Bottiglieri T, Wang X, Arning E, Fernandez H, Wall A, McKenna G, Ruiz R, Onaca N, Trotter J, Lawrence M, Naziruddin B, Asrani SK, Testa G. Longitudinal profiling of plasma and urine metabolites during liver regeneration in living liver donors. Clin Transplant. 2022 Jan;36(1):e14490. doi: 10.1111/ctr.14490. Epub 2021 Oct 1.

Reference Type DERIVED
PMID: 34545967 (View on PubMed)

Other Identifiers

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013-140

Identifier Type: -

Identifier Source: org_study_id

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