Liver InsufficiencyNCT01922323
Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
An observational study of Liver Insufficiency, run by Baylor Research Institute at 1 site in United States.
Trial summary
The PI will study metabolism during liver regeneration in living liver donors Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Insufficiency
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 26 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be comprised of living liver donors.
Who may be able to join
- 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.
Who cannot join
- 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.
- -
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
The PI will study metabolism during liver regeneration in living liver donors
Read the 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.
- Conditions
- Liver Insufficiency
- Keywords
- Living liver donor
- Medical subject headings
- Hepatic Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterized Metabolic Changes during liver regeneration
Measured: one year after donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver InsufficiencyStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuliano Testa, MD, Principal investigator, Sammons Cancer Center, Baylor University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922323
- Sponsor's protocol ID
- 013-140
- Status last verified
- Mar 2017
- First submitted
- 12 Aug 2013
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34545967
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
- ClinicalTrials.gov ID
- NCT01922323
- Acronym / sponsor ID
- 013-140
- Conditions
- Liver Insufficiency
- Keywords
- Living liver donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PI will study metabolism during liver regeneration in living liver donors
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be comprised of living liver donors.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- -
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterized Metabolic Changes during liver regeneration
Time frame: one year after donation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Derived from this study: PubMed 34545967Bottiglieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuliano Testa, MD principal investigator
Sammons Cancer Center, Baylor University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Insufficiency, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterized Metabolic Changes during liver regeneration (time frame: one year after donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.