We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

This study is currently recruiting participants.
Verified September 2017 by Yazen Alnouti, University of Nebraska
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200082
First Posted: September 13, 2010
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yazen Alnouti, University of Nebraska
August 31, 2010
September 13, 2010
September 11, 2017
November 2011
December 31, 2020   (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 ]
Bile acids (BAs), the end products of cholesterol metabolism, are synthesized in liver and excreted into bile, which flows to the small intestine via the bile duct. Most of the BAs are reabsorbed from the intestine into the portal circulation and undergo enterohepatic recirculation with minimal levels detected in urine and blood under normal conditions.
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 ]
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) ]
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
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

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.

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.

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.

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
    Male or female, age 19-65, no apparent signs of hepatobiliary diseases
  • Patients with hepatobiliary diseases
    Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 31, 2020
December 31, 2020   (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 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases

Exclusion Criteria:

  • MELD score less than 6
Sexes Eligible for Study: All
19 Years to 65 Years   (Adult)
Yes
Contact: Yazen M Alnouti, Ph.D 402-559-4631 yalnouti@unmc.edu
United States
 
 
NCT01200082
487-10-EP
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Yazen Alnouti, University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Yazen M Alnouti, Ph.D University of Nebraska
University of Nebraska
September 2017