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
  Purpose

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.


Condition
Hepatobiliary Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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]).


Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 400
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Controls
Patients with hepatobiliary diseases

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200082

Contacts
Contact: Yazen M Alnouti, Ph.D 402-559-4631 yalnouti@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medial Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: LuAnn Larson, Nurse    402-559-8555    llarson@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Yazen M Alnouti, Ph.D University of ebraska Medical Center
  More Information

Publications:
Responsible Party: Yazen M Alnouti/Assistant Professor, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01200082     History of Changes
Other Study ID Numbers: 487-10-EP
Study First Received: August 31, 2010
Last Updated: October 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
chronic hepatitis C/B
alcoholic liver disease
primary biliary cirrhosis
primary sclerosing cholangitis
progressive familial intrahepatic cholestasis

ClinicalTrials.gov processed this record on October 29, 2014