NCT01922323

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

August 12, 2013

Last Update Submit

March 27, 2017

Conditions

Liver Insufficiency

Keywords

Living liver donor

Outcome Measures

Primary Outcomes (1)

  • Characterized Metabolic Changes during liver regeneration

    one year after donation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will be comprised of living liver donors.

You may qualify if:

  • Potential donor must be in excellent medical and psychological health.
  • Potential donor must be between the ages of 18 and 60.
  • Must have a compatible blood type to the recipient.
  • Must have health care coverage for non-donor related health issues that arise post donation
  • Recipient and donor must have compatible body size.
  • Donors Body Mass Index (BMI) must be less than 30.
  • All previous donor abdominal surgeries will be reviewed on a case by case basis by the surgeon.

You may not qualify if:

  • Positive blood test for Human Immunodeficiency Virus, Hepatitis C virus, Hepatitis B virus
  • The size of the donor liver is not large enough to safely resection and still retain enough volume to function normally after the surgery.
  • Liver biopsy show liver cirrhosis or early stages of HCC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (1)

  • 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.

    PMID: 34545967DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each subject will provide samples of urine and blood at specific timepoints as outlined in the protocol

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Giuliano Testa, MD

    Sammons Cancer Center, Baylor University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

August 1, 2013

Primary Completion

September 26, 2016

Study Completion

September 26, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(1)