Metabolomics of Liver Regeneration Following Partial Hepa... | NCT01922323

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

NCT01922323

Sponsor

Baylor Research Institute

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Liver Insufficiency

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Sep 26, 2016Actual

Completion Date

Sep 26, 2016Actual

First Submitted Date

Aug 12, 2013

First Submission Date that Met QC Criteria

Aug 12, 2013

First Posted Date

Aug 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

-

-

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

The study population will be comprised of living liver donors.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuliano Testa, MD	Sammons Cancer Center, Baylor University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University Medical Center		Dallas	Texas	75246	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34545967	Derived	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.

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases