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Study Purpose:
In this study, we would like to determine the variation
in body fat distribution and blood chemistry in patients
with fatty liver disease. We also would like to know
how these parameters affect the circulating leptin
concentrations.
Research Abstract:
Being overweight impairs the action of the insulin
hormone, the primary hormone responsible for controlling
sugar levels in the body. This is called a state of
insulin resistance. Insulin resistance is commonly
seen in patients who have fat accumulation in their
liver. About 10% of patients with fat accumulation
in their liver develop scarring that can lead to failure
of liver and death. Another factor that has been shown
in research studies to play a role in preventing fat
accumulation in the liver is the leptin hormone, a
hormone secreted by the fat cells. Previously, we
have observed very low leptin hormone concentrations
in an unusual group of patients with abnormal body
fat. In this group, there was marked fat accumulation
and scarring in the liver as well as very severe insulin
resistance. Both the liver problem and the insulin
resistance remarkably reversed when we administered
leptin hormone and achieved near normal leptin levels
in these patients for about 4 months. These results
made us wonder whether leptin hormone plays a role
in the fat accumulation and scarring process in other
patients with this condition. However, knowledge about
the variation of leptin hormone levels and body composition
and how these relate to each other and insulin resistance
is lacking. In this study, we would like to determine
the variation in body fat distribution and blood chemistry
in patients with fatty liver disease. We also would
like to know how these parameters affect the circulating
leptin concentrations. This study comprises of one
day of testing that involves baseline blood work,
imagining studies that help to determine body fat
distribution and a test that lasts three hours to
determine how effective insulin is working in the
cells. We will perform these studies on 50 patients
with known fat accumulation and scarring. We will
use this information to determine if we can develop
new therapies to reverse or slow down fat accumulation
and scarring in the liver.
Eligibility Criteria:
Patients who were found to have nonalcoholic
steatohepatitis on their liver biopsy
Male patients between the age of 18 and 65
We exclude patients with other known causes
of liver disease
We exclude patients who have diabetes
mellitus
Patients whoare pregnant or lactating are ineligible
Patients with complicated diseases such as
kidney or heart failure are ineligible
Compensation: $50 per day of participation
The studies in Phase I will only take one day.
Contact Us:
If you are interested in participating as a subject
in this study, please contact Dr. Oral's study coordinator, Annie Boullion, at (734) 615-0539.
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