Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
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|ClinicalTrials.gov Identifier: NCT01200082|
Recruitment Status : Recruiting
First Posted : September 13, 2010
Last Update Posted : April 16, 2019
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases|
|Actual Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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
- 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.
- 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]).
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200082
|Contact: Yazen M Alnouti, Ph.Dfirstname.lastname@example.org|
|United States, Nebraska|
|University of Nebraska Medial Center||Recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: LuAnn Larson, Nurse 402-559-8555 email@example.com|
|Principal Investigator:||Yazen M Alnouti, Ph.D||University of Nebraska|