NCT01922323

Completed

Metabolomics of Liver Regeneration Following Partial Hepatec...

Baylor Research Institute Source

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Other study identifiers

Sponsor study identifier

013-140

Study Type

observational

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 26, 2016

Actual (reported)

Study Completion

September 26, 2016

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: September 26, 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 12, 2013
Actual (reported)
First Posted
August 14, 2013
Actual (reported)
Primary Completion
September 26, 2016
Actual (reported)
Study Completion
September 26, 2016
Actual (reported)

Last Updated: March 28, 2017
Status Verified: March 2017
Last Update Submitted: 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.

Sponsors & Collaborators

Baylor Research Institute
Otherlead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

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

Enrollment

20 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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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.

Primary Completion

September 26, 2016

Actual (reported)

Study Completion

September 26, 2016

Actual (reported)

Last Updated

March 28, 2017

Record last verified: 2017-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01922323
Data provider: ClinicalTrials.gov
Source updated: 2017-03-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:37 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations