Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
NCT ID: NCT01200082
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
430 participants
OBSERVATIONAL
2011-11-30
2022-09-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Controls
Male or female, age 19-65, no apparent signs of hepatobiliary diseases
No interventions assigned to this group
Patients with hepatobiliary diseases
Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases
Exclusion Criteria
Patient Population
* MELD score less than 6
19 Years
65 Years
ALL
Yes
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Yazen M Alnouti, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medial Center
Omaha, Nebraska, United States
Countries
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References
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Simko V, Michael S. Urinary bile acids in population screening for inapparent liver disease. Hepatogastroenterology. 1998 Sep-Oct;45(23):1706-14.
Makino I, Hashimoto H, Shinozaki K, Yoshino K, Nakagawa S. Sulfated and nonsulfated bile acids in urine, serum, and bile of patients with hepatobiliary diseases. Gastroenterology. 1975 Mar;68(3):545-53.
Alme B, Bremmelgaard A, Sjovall J, Thomassen P. Analysis of metabolic profiles of bile acids in urine using a lipophilic anion exchanger and computerized gas-liquid chromatorgaphy-mass spectrometry. J Lipid Res. 1977 May;18(3):339-62.
Other Identifiers
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0487-10-EP
Identifier Type: -
Identifier Source: org_study_id
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