Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 22 - 65 |
| Updated: | 8/9/2018 |
| Start Date: | January 2012 |
| End Date: | June 2019 |
HepQuant tests are new liver tests that are being developed to accurately measure liver
function with sensitivity and specificity while being safe and non-invasive. The primary goal
of this study is to define the intra-individual reproducibility of the HepQuant tests, that
is, to see if a person is given the tests several times that the test results are essentially
the same each time. Subjects for this study will include healthy controls and patients with
chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV)
infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis
(NASH). The HCV and NASH patients will include men and women, and those with early stage and
late stage liver disease as defined by the amount of fibrosis observed in their liver
biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests
on three separate days within the span of one month. The hypothesis of this study is that
HepQuant tests will reproducibly report liver function in healthy controls and patients with
all stages of chronic HCV and NASH liver disease and that liver function will decrease as the
amount of liver fibrosis increases in the chronic liver disease patients.
function with sensitivity and specificity while being safe and non-invasive. The primary goal
of this study is to define the intra-individual reproducibility of the HepQuant tests, that
is, to see if a person is given the tests several times that the test results are essentially
the same each time. Subjects for this study will include healthy controls and patients with
chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV)
infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis
(NASH). The HCV and NASH patients will include men and women, and those with early stage and
late stage liver disease as defined by the amount of fibrosis observed in their liver
biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests
on three separate days within the span of one month. The hypothesis of this study is that
HepQuant tests will reproducibly report liver function in healthy controls and patients with
all stages of chronic HCV and NASH liver disease and that liver function will decrease as the
amount of liver fibrosis increases in the chronic liver disease patients.
Inclusion Criteria:
- Diagnosis of chronic HCV or NASH
- Liver biopsy within 2 years of enrollment
- Compensated liver disease
Exclusion Criteria:
- Decompensated liver disease
- Currently being treated with beta blockers, ACE inhibitors, or other agents affecting
FMD
- Malignancy diagnosed within 5 years of study enrollment without demonstrated clearance
- History of congestive heart failure
- Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)
- Crohn's disease or any active intestinal inflammatory condition
- Having an ileal resection
- Diabetic Gastroparesis
- Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed at
each visit.
- Inability to consent for one's self
We found this trial at
1
site
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
Click here to add this to my saved trials
