Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01200082
First received: August 31, 2010
Last updated: October 15, 2010
Last verified: October 2010

August 31, 2010
October 15, 2010
December 2010
December 2011   (final data collection date for primary outcome measure)
Urinary bile acid indexes [ Time Frame: Healthy controls: 4 visits over 28 days. Patients: urine collction at every visit as decided in their course of treatment ] [ Designated as safety issue: No ]
Urnianry bile acid indexes [ Time Frame: Healthy controls: 4 visits over 28 days. Patients: urine collction at every visit as decided in their course of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01200082 on ClinicalTrials.gov Archive Site
mayo model for end-stage liver disease score (MELD) [ Time Frame: Healthy controls: 1st visit only (1 week). Patients: every time a MELD score is required by hepatologists as partrt of their regular course of treatment (1 year) ] [ Designated as safety issue: No ]
MELD score= 3.8*loge (bilirubin [mg/dL]) + 11.2*loge (INR) + 9.6*loge (creatinine [mg/dL]).
Same as current
Not Provided
Not Provided
 
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
Not Provided

The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases. The investigators rationale in this project is that the discovery of biomarkers specific to liver injury would provide the foundation for a specific and non-invasive tool to evaluate disease prognosis, determine patients with higher risk of developing end-stage liver diseases, and determine patients with higher risk of recurrence of hepatobiliary complications after liver transplant. The investigators propose the following specific aims to test the investigators hypothesis:

Specific Aim #1: Establish a baseline of individual and total urinary BAs and BA-sulfates in healthy controls and patients with hepatobiliary diseases. A baseline reference of the average and distribution of the percentage of urinary BA-sulfates will be determined in healthy subjects and in patients with hepatobiliary diseases including chronic hepatitis C/B, alcoholic liver disease, hereditary, drug-induced, and autoimmune hepatobiliary diseases. The investigators working hypothesis is that patients' capability to sulfate total or specific BAs, as determined by the percentage of total or specific BAs excreted in the sulfate form, can predict the severity of hepatobiliary diseases, as determined by mayo model for end-stage liver disease (MELD) score and compensation status(compensated and decompensated). Patients with higher MELD score are considered to be at higher risk of developing severe hepatobiliary complications.

Specific Aim #2: Determine the relationship between BA sulfation and the progression of hepatobiliary diseases. This is an exploratory aim to collect preliminary data on the relationship between urinary BAs and the progression of hepatobiliary diseases in liver-transplant and non-liver-transplant patients, as monitored over a1-year period. The investigators working hypothesis is that patients' capabilities of sulfating BAs determine the progression of the disease.

Patients on the liver transplant list are continuously monitored during their hospitalization and are scheduled for follow-up visits for 12 months after their release post-surgery. Disease progression will be evaluated by monitoring MELD scores, survival, incidence of liver transplant, and incidence of complications related to hepatobiliary conditions such as fluid retention, GI bleeding, encephalopathy, and biliary stricture complications.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

lood samples will be collected from healthy volunteers at their 1st visit. Urine samples will be obtained from healthy controntrols and patients with hepatobiliary diseases over time.

Non-Probability Sample

Healthy Controls: Subjects with no apparemt hepatobiliary diseases Patient Populaton: Subjects visiting the hepatology clinic in UNMC as part of their treatment of hepatobiliry diseases

Hepatobiliary Diseases
Not Provided
  • Healthy Controls
  • Patients with hepatobiliary diseases

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
December 2011
December 2011   (final data collection date for primary outcome measure)

Healthy Controls

Inclusion Criteria:

  • Male or female, age 19-65, no apparent signs of hepatobiliary diseases

Exclusion Criteria:

  • Levels higher than 50, 56, 78 U/L for ALT, AST, and GGT, respectively.

Patient Population

Inclusion Criteria:

  • Male or female, age 18-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases

Exclusion Criteria:

  • MELD score less than 6
Both
19 Years to 65 Years
Yes
Contact: Yazen M Alnouti, Ph.D 402-559-4631 yalnouti@unmc.edu
United States
 
NCT01200082
487-10-EP
No
Yazen M Alnouti/Assistant Professor, University of Nebraska Medical Center
University of Nebraska
Not Provided
Principal Investigator: Yazen M Alnouti, Ph.D University of ebraska Medical Center
University of Nebraska
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP